Clinical Trials

Numerous clinical trials spanning Early Phase 1 to Phase 4 evaluate levonorgestrel for indications such as contraception, irregular periods, and intrauterine device insertion complications, alongside pharmacokinetic and drug-drug interaction assessments in healthy volunteers and patients with obesity, non-alcoholic steatohepatitis, or systemic scleroderma. Sponsored by various pharmaceutical corporations and academic institutions, these studies represent several recruitment statuses, including recruiting, active not recruiting, completed, and terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07449299 NOT_YET_RECRUITING
Emergency Contraception; Contraception; COX-2 Inhibitor
University of Utah
2027-03 PHASE3
NCT07462663 NOT_YET_RECRUITING
Endometrial Cancer; Endometrial Cancer Stage I; Atypical Endometrial Hyperplasia and Endometrial Carcinoma Stage I; Atypical Endometrial Hyperplasia; Endometrial Intraepithelial Neoplasia; Obesity & Overweight; BMI>40; Obesity; Obesity Grade III
Hospital Universitari de Bellvitge
2027-01 PHASE4
NCT07734155 NOT_YET_RECRUITING
Contraceptive Usage
Chemo Research
2026-12 PHASE3
NCT07627958 NOT_YET_RECRUITING
Vaginal Microbial Diversity
Seattle Children's Hospital
2026-07
NCT07781150 NOT_YET_RECRUITING
Obesity; Overweight; Atypical Endometrial Hyperplasia; Endometrial Carcinoma Stage I; Endometrioid Endometrial Cancer
Tongji Hospital
2026-11-01 PHASE2
NCT07536763 NOT_YET_RECRUITING
Contraception
Dr. Hang Wun Raymond Li
2026-07 PHASE3
NCT06620939 NOT_YET_RECRUITING
Endometrial Polyp
Zhang Jian
2024-12-01
NCT07222228 NOT_YET_RECRUITING
Healthy Women; Female Contraception
Premier Research
2026-04-01 PHASE2
NCT07107334 RECRUITING
Endometrioid Endometrial Adenocarcinoma
University of Florida
2026-04-07 PHASE2
NCT05903131 RECRUITING
Endometrial Hyperplasia; Grade 1 Endometrial Cancer
Washington University School of Medicine
2024-10-24 PHASE2
NCT04948489 WITHDRAWN
Endometriosis
Boston Children's Hospital
2026-01-01 PHASE2
NCT06162611 RECRUITING
Emergency Contraception
Lori Gawron
2023-11-06 PHASE4
NCT06727734 RECRUITING
Contraception
The University of Hong Kong
2025-01-18 PHASE3
NCT07013643 RECRUITING
Healthy Participants
AstraZeneca
2025-06-04 PHASE1
NCT07759635 RECRUITING
Female; Premenopausal
McMaster University
2026-07-22
NCT07794150 RECRUITING
Menopause; Healthy Female Participants
Corium Innovations, Inc.
2026-08-10 PHASE1
NCT07710729 RECRUITING
Overweight; Obesity
Novo Nordisk A/S
2026-07-17 PHASE1
NCT07525791 RECRUITING
Overweight; Obesity
Novo Nordisk A/S
2026-04-07 PHASE1
NCT05444582 RECRUITING
Contraception
University of Utah
2022-11-07 PHASE4
NCT05044962 RECRUITING
HIV Infections; Contraception; Drug-drug Interaction
University of Alabama at Birmingham
2021-11-26
NCT05058872 RECRUITING
Oral Hormonal Contraceptive Use; Neural Activity; Mood; Hedonic Function
University of Colorado, Denver
2021-10-01 PHASE4
NCT05233956 ACTIVE_NOT_RECRUITING
Anemia
FHI 360
2023-10-23
NCT07784894 NOT_YET_RECRUITING
Tuberculosis
GlaxoSmithKline
2026-09-01 PHASE1
NCT07539090 RECRUITING
Healthy Participants
Deciphera Pharmaceuticals, LLC
2026-06-05 PHASE1
NCT02397083 ACTIVE_NOT_RECRUITING
Atypical Endometrial Hyperplasia; FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma; FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma
M.D. Anderson Cancer Center
2015-09-23 PHASE2
NCT07414784 COMPLETED
Healthy Volunteer
AbbVie
2026-02-11 PHASE1
NCT03708809 WITHDRAWN
Contraception
Sheba Medical Center
2023-12-01
NCT07502417 COMPLETED
Healthy Volunteer
AbbVie
2026-03-27 PHASE1
NCT06935968 NOT_YET_RECRUITING
Hemoglobin; Deficiency
Assiut University
2025-05-01
NCT07388511 COMPLETED
Healthy Participants
Blueprint Medicines Corporation
2026-02-05 PHASE1
NCT04143659 ACTIVE_NOT_RECRUITING
Healthy Women; Female Contraception
Premier Research
2020-03-03 PHASE1
NCT03557619 UNKNOWN
Hematologic Malignancies
AbbVie
2019-07-30 PHASE1
NCT05316493 RECRUITING
Atypical Endometrial Hyperplasia; Fertility Issues; Overweight and Obesity
Xiaojun Chen
2022-06-13 PHASE2; PHASE3
NCT07272889 COMPLETED
Healthy Volunteer Study
Atea Pharmaceuticals, Inc.
2025-12-04 PHASE1
NCT06942936 COMPLETED
Healthy Participants
AstraZeneca
2025-05-28 PHASE1
NCT07680985 COMPLETED
Adenomyosis
Wenzhou People's Hospital
2023-07-20
NCT03463252 RECRUITING
Endometrial Cancer; Atypical Endometrial Hyperplasia
West China Second University Hospital
2018-04-01 PHASE2; PHASE3
NCT05172999 COMPLETED
Atypical Endometrial Hyperplasia; Obesity; Fertility Issues
Fudan University
2022-01-08 PHASE2; PHASE3
NCT06306131 COMPLETED
Pregnancy Prevention
InnovaGyn, Inc.
2023-12-10 PHASE2
NCT06513104 COMPLETED
Diabetes Mellitus, Type 2
Novo Nordisk A/S
2024-07-18 PHASE1
NCT06019533 COMPLETED
Contraception
Chemo Research
2023-08-09 PHASE3
NCT06492889 UNKNOWN
Pregnancy Early; Pregnancy Related
Gynuity Health Projects
2024-07-22 PHASE2; PHASE3
NCT07229209 COMPLETED
Abnormal Uterine Bleeding; Cesarean Section Complications; Uterine Scar
Benha University
2025-02-05
NCT06461039 COMPLETED
Obesity
Novo Nordisk A/S
2024-06-14 PHASE1
NCT06799884 COMPLETED
Drug Drug Interaction
Idorsia Pharmaceuticals Ltd.
2025-01-18 PHASE1
NCT06671405 COMPLETED
Dyslipidaemia
AstraZeneca
2024-09-25 PHASE1
NCT05896384 COMPLETED
Healthy
Boehringer Ingelheim
2023-12-21 PHASE1
NCT06657105 COMPLETED
Healthy Participants
AstraZeneca
2024-11-01 PHASE1
NCT06188026 COMPLETED
Healthy Volunteers (Non-alcoholic Steatohepatitis)
Novo Nordisk A/S
2023-12-18 PHASE1
NCT04007874 UNKNOWN
Migraine; Migraine;Menstrual
Leiden University Medical Center
2019-09-10 PHASE3
NCT05695352 COMPLETED
Pregnancy Prevention
InnovaGyn, Inc.
2022-06-28 PHASE2
NCT05041699 COMPLETED
Pharmacokinetics; Safety Issues; Bleeding
International Partnership for Microbicides, Inc.
2022-06-20 PHASE1
NCT04897217 WITHDRAWN
Endometrial Hyperplasia
Wake Forest University Health Sciences
2023-06-30 PHASE3
NCT06689150 COMPLETED
Menstrual Bleeding, Heavy
Al-Azhar University
2023-08-10
NCT05700812 COMPLETED
IUD; IUD Insertion Complication; IUD; Complications
University of California, Davis
2023-02-01
NCT06354257 COMPLETED
Tuberculosis
GlaxoSmithKline
2024-04-05 PHASE1
NCT05565573 UNKNOWN
Fertility Sparing
Hua Li
2022-11-01 PHASE2; PHASE3
NCT06380205 COMPLETED
Healthy Participants
Incyte Corporation
2024-05-07 PHASE1
NCT05343546 UNKNOWN
Incomplete Abortion; Intrauterine Contraception; Misoprostol
Makerere University
2022-06
NCT06380205 Recruiting
Healthy Participants
Incyte Corporation
2024-05-07 Phase 1
NCT06500390 RECRUITING
Levonorgestrel Adverse Reaction; Temporomandibular Joint Disorders; Temporomandibular Disorder
Marmara University
2024-01-15
NCT06071442 COMPLETED
Healthy Participants
Alexion Pharmaceuticals, Inc.
2024-01-17 PHASE1
NCT06581679 COMPLETED
Adenomyosis
Zagazig University
2023-12-15
NCT06188026 Recruiting
Healthy Volunteers (Non-alcoholic Steatohepatitis)
Novo Nordisk A/S
2023-12-18 Phase 1
NCT05896384 Recruiting
Healthy
Boehringer Ingelheim
2023-12-07 Phase 1
NCT02035787 COMPLETED
Complex Atypical Hyperplasia; Endometrial Cancer
UNC Lineberger Comprehensive Cancer Center
2014-02-27 PHASE2
NCT06783192 COMPLETED
Human Immunodeficiency Virus (HIV); HIV Pre-Exposure Prophylaxis
Merck Sharp & Dohme LLC
2023-08-14 PHASE1
NCT05613777 COMPLETED
Healthy
Boehringer Ingelheim
2022-11-24 PHASE1
NCT04910711 UNKNOWN
Human Immunodeficiency Virus; Contraception; ART
Botswana Harvard AIDS Institute Partnership
2021-10-21 PHASE4
NCT05770297 UNKNOWN
Endometriosis; Dysmenorrhea
Indonesia University
2022-07-12
NCT05700812 Recruiting
IUD|IUD Insertion Complication|IUD; Complications
University of California Davis
2023-02-01 Not Applicable
NCT05505162 COMPLETED
Healthy Female Participants
AstraZeneca
2022-08-24 PHASE1
NCT05671653 Terminated
Obesity
Pfizer
2023-01-19 Phase 1
NCT04814927 COMPLETED
Mucosal Inflammation; Contraceptive; Complications, Intrauterine
Eastern Virginia Medical School
2021-03-01 PHASE4
NCT04385667 COMPLETED
Atypical Endometrial Hyperplasia
Zagazig University
2020-05-20 PHASE2; PHASE3
NCT05594186 COMPLETED
Intermenstrual Bleeding
Saudi German Hospital - Madinah
2019-03-01
NCT03614494 COMPLETED
Emergency Contraception
Dr. Hang Wun Raymond Li
2018-08-20 PHASE2; PHASE3
NCT01686126 ACTIVE_NOT_RECRUITING
Complex Endometrial Hyperplasia With Atypia; Grade 1 Endometrial Endometrioid Adenocarcinoma
Queensland Centre for Gynaecological Cancer
2012-12 PHASE2
NCT03745144 COMPLETED
Relapsing Multiple Sclerosis (RMS)
Merck KGaA, Darmstadt, Germany
2019-01-17 PHASE1
NCT05153564 COMPLETED
Diabetes Mellitus, Type 2
Novo Nordisk A/S
2021-12-13 PHASE1
NCT05093205 COMPLETED
Healthy Adults
Pfizer
2021-10-25 PHASE1
NCT02799641 COMPLETED
Contraception
TriHealth Inc.
2016-07
NCT04972396 COMPLETED
NASH - Nonalcoholic Steatohepatitis
Altimmune, Inc.
2021-09-15 PHASE1
NCT03537768 TERMINATED
Contraception
Kimberly Myer
2018-07-12 PHASE4
NCT03043924 COMPLETED
Polycystic Ovary Syndrome
University Hospital, Lille
2017-09-26
NCT05282940 COMPLETED
Therapeutic Equivalency
Laboratorios Andromaco S.A.
2022-02-26 PHASE1
NCT02556411 UNKNOWN
Adenomyosis; Chronic Pelvic Pain
University of Cagliari
2021-06-01
NCT04663568 TERMINATED
Tubal Ligation
Assiut University
2020-12-01
NCT04676776 UNKNOWN
Missed Menstrual Period
Gynuity Health Projects
2021-01-25 PHASE2
NCT07739589 COMPLETED
Residual Drug Amount of EE and LNG
Insud Pharma
2021-10-25 PHASE4
NCT04500028 COMPLETED
IUCD Complication
Aswan University Hospital
2020-08-01 PHASE4
NCT03642210 COMPLETED
Menorrhagia
Medicines360
2019-01-17 PHASE3
NCT00995150 TERMINATED
Contraception
Medicines360
2009-11 PHASE3
NCT04517890 UNKNOWN
IUCD Complication
Aswan University Hospital
2020-09-01
NCT04872244 COMPLETED
Isthmocele; Post-menstrual Spotting Bleeding; Pelvic Pain
Gaziosmanpasa Research and Education Hospital
2019-11-03
NCT02985541 COMPLETED
Contraception
Bayer
2016-12-22 PHASE3
NCT04339348 COMPLETED
Contraception
Cairo University
2020-04-30 PHASE3
NCT02863445 COMPLETED
Obesity
Oregon Health and Science University
2017-07-06 PHASE4
NCT03317795 COMPLETED
Heavy Menstrual Bleeding; Menorrhagia; Uterine Fibroids
Shannon K. Laughlin-Tommaso
2017-11-14 PHASE4
NCT03992937 COMPLETED
Endometrial Hyperplasia Without Atypia
Kocaeli University
2019-06-20
NCT04194905 COMPLETED
Bioequivalence
Laboratorios Andromaco S.A.
2020-11-21 PHASE1
NCT04267250 COMPLETED
Healthy Female Volunteers
Pfizer
2020-08-24 PHASE1
NCT03819114 COMPLETED
HIV Infections; Tuberculosis
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
2019-05-06 PHASE2
NCT04230070 COMPLETED
Bioequivalence
Laboratorios Andromaco S.A.
2020-10-24 PHASE1
NCT02957292 COMPLETED
Contraception
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
2016-06-01 PHASE4
NCT04339361 UNKNOWN
Contraception
Cairo University
2020-04-25 PHASE4
NCT04355598 UNKNOWN
Contraception
Cairo University
2020-04-30 PHASE4
NCT04312061 UNKNOWN
Contraception
Cairo University
2020-03-30 PHASE3
NCT04311658 UNKNOWN
Contraception
Cairo University
2020-03-30 PHASE3
NCT04309643 COMPLETED
Healthy Volunteers
Concert Pharmaceuticals
2020-06-09 PHASE1
NCT03241888 COMPLETED
Atypical Endometrial Hyperplasia
Fudan University
2017-07-04 PHASE2; PHASE3
NCT03241914 COMPLETED
Endometrial Neoplasm Malignant Stage I
Fudan University
2017-07-04 PHASE2; PHASE3
NCT04074174 COMPLETED
Overweight; Obesity
Novo Nordisk A/S
2019-09-12 PHASE1
NCT03455075 COMPLETED
Healthy; Men; Male Contraception
Premier Research
2018-04-16 PHASE2
NCT02175030 COMPLETED
Contraception
University of Utah
2016-08 PHASE4
NCT04142762 COMPLETED
Chronic Hepatitis B
Assembly Biosciences
2019-10-18 PHASE1
NCT04045548 COMPLETED
Intrauterine Device
Cairo University
2019-08-10 PHASE4
NCT03954366 COMPLETED
Neoplasms
pharmaand GmbH
2019-04-25 PHASE1
NCT02722421 COMPLETED
HIV; Contraception
University of Nebraska
2017-04-06 PHASE2
NCT02357368 COMPLETED
HIV; Contraception
Lisa Haddad
2015-02 PHASE4
NCT04018274 COMPLETED
Healthy
Pfizer
2019-08-09 PHASE1
NCT03675581 COMPLETED
Scleroderma, Systemic
Boehringer Ingelheim
2018-11-08 PHASE1
NCT03709355 COMPLETED
HIV-1-infection
Viriom
2018-11-14 PHASE1
NCT03467347 COMPLETED
Healthy; Contraception; Contraceptive Usage; Women
International Partnership for Microbicides, Inc.
2018-07-17 PHASE1
NCT03762382 UNKNOWN
HIV; Contraception; Prevention; Anti-Retroviral Agent
CONRAD
2018-12-12 PHASE2
NCT03984825 COMPLETED
HIV Infections
ViiV Healthcare
2019-06-13 PHASE1
NCT02002260 UNKNOWN
Abnormal Uterine Bleeding; Abnormal Uterine Bleeding, Ovulatory Dysfunction; Abnormal Uterine Bleeding, Endometrial Hemostatic Dysfunction
Women and Infants Hospital of Rhode Island
2013-02
NCT03589027 UNKNOWN
HIV-1-infection; Contraception
Makerere University
2018-08-07 PHASE2
NCT03562624 COMPLETED
Contraception
Bayer
2018-06-22 PHASE2
NCT03662516 COMPLETED
Healthy Females
Pfizer
2018-09-26 PHASE1
NCT03279120 COMPLETED
Anti-Infective Agents; Anti-Retroviral Agents; Contraceptive Usage
CONRAD
2017-09-28 PHASE1
NCT01539720 COMPLETED
Pregnancy, Unplanned; Pregnancy; Accident
Planned Parenthood of the St. Louis Region and Southwest Missouri
2012-12
NCT02550067 COMPLETED
HIV; Contraception
FHI 360
2015-12-14
NCT03506399 WITHDRAWN
Healthy
Eli Lilly and Company
2018-06 PHASE1
NCT03074045 COMPLETED
Contraception
Bayer
2017-03-13 PHASE3
NCT03111342 COMPLETED
Pain, Acute; Anesthesia, Local; IUD Insertion Complication
University of Sao Paulo
2017-06-01 PHASE4
NCT03547024 COMPLETED
Healthy
Janssen-Cilag International NV
2018-06-08 PHASE1
NCT02882191 COMPLETED
Contraception
Sebela Women's Health Inc.
2016-11 PHASE2
NCT03301207 COMPLETED
Leukemia, Lymphocytic, Chronic, B-Cell
Janssen Research & Development, LLC
2017-10-20 PHASE1
NCT01721798 COMPLETED
HIV
FHI 360
2013-11-10
NCT03353857 COMPLETED
Biological Availability
Bayer
2017-11-29 PHASE1
NCT02475265 COMPLETED
Anorexia Nervosa; Osteoporosis
Massachusetts General Hospital
2015-07 PHASE2
NCT03210246 COMPLETED
Clinical Trial ,Phase I
Bayer
2017-07-17 PHASE1
NCT03353012 COMPLETED
Breastfeeding; Post Partum
Chulalongkorn University
2018-01-01 PHASE4
NCT03324685 COMPLETED
Drug Interactions
Biogen
2017-11-11 PHASE1
NCT02824224 COMPLETED
Menorrhagia; Metrorrhagia; Medicated Intrauterine Devices
Oregon Health and Science University
2016-09-06 PHASE4
NCT01941134 WITHDRAWN
Bariatric Surgery Candidate; Contraception
Johns Hopkins University
2013-04 PHASE4
NCT03037944 UNKNOWN
Adenomyosis
Ain Shams Maternity Hospital
2016-03-01 EARLY_PHASE1
NCT03193307 COMPLETED
Healthy
Boehringer Ingelheim
2017-06-29 PHASE1
NCT02751385 TERMINATED
Carcinoma, Non-Small-Cell Lung
Boehringer Ingelheim
2016-05-20 PHASE1
NCT03249402 COMPLETED
Healthy
Janssen-Cilag International NV
2017-08-14 PHASE1
NCT02451826 UNKNOWN
Ovulation Inhibition
Population Council
2015-05 PHASE1; PHASE2
NCT02599077 SUSPENDED
Endometriosis
Fundación Santa Fe de Bogota
2015-11 PHASE2; PHASE3
NCT02697851 TERMINATED
HIV
St Stephens Aids Trust
2016-07 PHASE1
NCT02957630 COMPLETED
Contraception; Liver Metabolism; Hemostasis Parameter
Estetra
2016-09 PHASE1; PHASE2
NCT02855346 COMPLETED
HIV Prevention
International Partnership for Microbicides, Inc.
2017-05-03 PHASE1
NCT02480647 COMPLETED
Endometriosis
University of Campinas, Brazil
2016-05 PHASE4
NCT02577601 COMPLETED
Contraception
Oregon Health and Science University
2015-09-08 PHASE4
NCT02846142 COMPLETED
Healthy Volunteer
Proteostasis Therapeutics, Inc.
2016-06 PHASE1
NCT02845219 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2016-07 PHASE1
NCT01990703 COMPLETED
Contraception
University of Utah
2014-01 PHASE4
NCT02531321 TERMINATED
Contraception; HIV
University of Southern California
2015-08 PHASE4
NCT02203331 COMPLETED
Endometriosis
Bayer
2014-10-16 PHASE2
NCT02616146 TERMINATED
Contraception
Organon and Co
2015-12-01 PHASE3
NCT01943058 WITHDRAWN
Atypical Endometrial Hyperplasia; Endometrial Adenocarcinoma; Recurrent Endometrial Carcinoma; Stage IA Endometrial Carcinoma; Stage IB Endometrial Carcinoma; Stage II Endometrial Carcinoma; Stage IIIA Endometrial Carcinoma; Stage IIIB Endometrial Carcinoma; Stage IIIC Endometrial Carcinoma; Stage IVA Endometrial Carcinoma; Stage IVB Endometrial Carcinoma
University of Southern California
2014-03 PHASE2
NCT02403401 COMPLETED
Contraception
Bayer
2015-05-15 PHASE3
NCT03104309 COMPLETED
Adenomyosis
Assiut University
2015-06
NCT00788671 ACTIVE_NOT_RECRUITING
Atypical Endometrial Hyperplasia; Stage I Uterine Corpus Cancer AJCC v7; Stage IA Uterine Corpus Cancer AJCC v7; Stage IB Uterine Corpus Cancer AJCC v7; Stage II Uterine Corpus Cancer AJCC v7
M.D. Anderson Cancer Center
2008-11-03 PHASE2
NCT02121067 COMPLETED
Contraception; Malposition of Intrauterine Contraceptive Device
University of North Carolina, Chapel Hill
2014-09 PHASE4
NCT02341027 COMPLETED
Contraceptive Implant Utilization; Lactation
University of California, San Francisco
2015-01
NCT02534688 COMPLETED
Endometriosis
King Chulalongkorn Memorial Hospital
2015-06 PHASE4
NCT02894151 COMPLETED
Clinically Diagnosed Endometriotic Patient Was Defined as a Woman Who Has Pelvic Pain and at Least One Evidence of PV or TVS
Chulalongkorn University
2015-04 PHASE2
NCT02545452 COMPLETED
Endometriosis
Bayer
2015-09-15 PHASE1
NCT02326922 COMPLETED
Dysfunctional Uterine Bleeding
Ain Shams Maternity Hospital
2014-06 PHASE1; PHASE2
NCT02689804 COMPLETED
Contraception
Columbia University
2015-07-10 PHASE4
NCT03305081 TERMINATED
Contraception
Tulane University School of Medicine
2014-10-22
NCT02235662 COMPLETED
HIV; Contraception
CONRAD
2014-10 PHASE1
NCT01165307 COMPLETED
Menorrhagia
Abimbola Famuyide
2009-08 PHASE4
NCT01480778 COMPLETED
Irregular Periods
Azidus Brasil
2014-07 PHASE3
NCT02159326 COMPLETED
Drug Interactions
Bayer
2014-06 PHASE1
NCT02021097 UNKNOWN
Oral Contraceptive
Regenex Pharmaceutical, China
2012-02 PHASE3
NCT01594879 UNKNOWN
Endometrial Cancer
Korean Gynecologic Oncology Group
2012-01 PHASE2
NCT02170038 COMPLETED
Pharmacokinetics
Bayer
2014-06 PHASE1
NCT03027648 COMPLETED
Adenomyosis
Peking Union Medical College Hospital
2006-12
NCT02159131 COMPLETED
Infections, Human Immunodeficiency Virus and Hepatitis
ViiV Healthcare
2014-08 PHASE1
NCT01286948 COMPLETED
Female Contraception
Population Council
2011-01 PHASE1
NCT01789879 COMPLETED
HIV; Contraception
University of Nebraska
2014-03-04 PHASE2
NCT02085863 COMPLETED
Pharmacokinetics; Pharmacodynamics
Teva Branded Pharmaceutical Products R&D, Inc.
2014-02 PHASE1
NCT01161095 WITHDRAWN
Contraception; Postpartum Period
United States Naval Medical Center, Portsmouth
2010-07-01
NCT01594476 TERMINATED
Contraception
Oregon Health and Science University
2012-03 PHASE4
NCT02362373 COMPLETED
Epilepsy; Contraception
Columbia University
2011-08 PHASE4
NCT01941615 TERMINATED
Healthy
Boehringer Ingelheim
2013-11 PHASE1
NCT00445887 COMPLETED
Ovarian Carcinoma
Gynecologic Oncology Group
2008-03-10 PHASE2
NCT01074892 COMPLETED
Endometrial Hyperplasia
University Hospital of North Norway
2005-05 PHASE4
NCT01805817 WITHDRAWN
Contraceptive Methods Comparison
Istanbul Training and Research Hospital
2012-12 PHASE4
NCT03359057 COMPLETED
Contraception
Galeno Desenvolvimento de Pesquisas Clínicas
2013-02-26 PHASE3
NCT02155166 COMPLETED
Pain
University of Sao Paulo
2012-02
NCT00884260 COMPLETED
Contraception
Bayer
2009-04 PHASE3
NCT01434160 COMPLETED
Contraception
Bayer
2011-09 PHASE3
NCT01555931 COMPLETED
Postpartum Contraception
University of North Carolina, Chapel Hill
2012-03 PHASE4
NCT01601366 COMPLETED
Adenomyosis
Omar Mamdouh Shaaban
2012-04 PHASE2
NCT01254292 COMPLETED
Contraception
Bayer
2011-01-06 PHASE3
NCT01391052 UNKNOWN
Heavy Menstrual Bleeding; Menorrhagia; Hypermenorrhea
Scott and White Hospital & Clinic
2011-01 PHASE4
NCT01615354 COMPLETED
Healthy Volunteer
Hoffmann-La Roche
2012-07 PHASE1
NCT01234818 UNKNOWN
Endometrial Hyperplasia
Korean Gynecologic Oncology Group
2010-11 PHASE2
NCT00393198 COMPLETED
Contraception; Menorrhagia
Bayer
2006-10 PHASE4
NCT01623466 COMPLETED
Healthy
Agile Therapeutics
2012-07 PHASE1; PHASE2
NCT02158845 COMPLETED
Endometriosis
University of Sao Paulo
2010-02 PHASE4
NCT01570244 COMPLETED
Hepatitis C, Chronic
Boehringer Ingelheim
2012-04 PHASE1
NCT01569113 COMPLETED
Emergency Contraception
HRA Pharma
2012-03 PHASE4
NCT00924560 COMPLETED
Bone Mineral Density
Duramed Research
2009-06 PHASE2
NCT00584610 UNKNOWN
Blood Coagulation Disorders
University of Vermont
2007-12
NCT01166412 COMPLETED
Contraception
Premier Research
2010-12 PHASE1; PHASE2
NCT01546454 COMPLETED
Coronary Heart Disease
Oregon Health and Science University
2012-02
NCT02173808 COMPLETED
Contraceptive Usage
Premier Research
2011-05 PHASE1
NCT01501448 COMPLETED
Infertility
IVI Madrid
2012-01 PHASE4
NCT01291004 COMPLETED
Follicle Development; Ovarian Follicle; Follicle Count; Follicle Size; Oral Contraceptive
Teva Branded Pharmaceutical Products R&D, Inc.
2011-01-31 PHASE1
NCT01324505 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2011-03 PHASE1
NCT01295294 COMPLETED
Uterine Hemorrhage
Bayer
2011-03 PHASE4
NCT01252186 COMPLETED
Hemostasis; Oral Contraceptive
Teva Women's Health
2010-11 PHASE2
NCT01240811 COMPLETED
Genital Tract Mucosal Immunity; Genital Tract Microflora
Sharon Achilles
2010-11
NCT00123175 WITHDRAWN
Endometrial Hyperplasia
Milton S. Hershey Medical Center
2009-09 PHASE1; PHASE2
NCT01388582 COMPLETED
Underweight
University of Campinas, Brazil
2011-04 PHASE4
NCT00781456 COMPLETED
Migraine
Duramed Research
2009-01 PHASE2
NCT01320917 UNKNOWN
Contraception Desired; Obesity
University of Sao Paulo
2009-02 PHASE4
NCT01328184 COMPLETED
Healthy
Boehringer Ingelheim
2011-04 PHASE1
NCT00528112 COMPLETED
Contraception
Bayer
2007-08 PHASE3
NCT01598662 TERMINATED
Contraception
University of Louisville
2009-07
NCT00635362 TERMINATED
Healthy
University of Chicago
2007-05
NCT00909857 COMPLETED
Primary Dysmenorrhea
Bayer
2009-04 PHASE3
NCT00922233 COMPLETED
Healthy
FHI 360
2010-01 PHASE3
NCT01230242 TERMINATED
Estimating Rates of Expulsion
Rebecca Hunt
2010-09-07
NCT00570440 COMPLETED
Pregnancy Prevention
FHI 360
2007-08 PHASE4
NCT00433004 COMPLETED
Post Partum
University of Pennsylvania
2007-02 PHASE4
NCT00997932 COMPLETED
Unplanned Pregnancy
University of North Carolina, Chapel Hill
2009-06 PHASE4
NCT00933179 COMPLETED
Contraception
Bayer
2009-06 PHASE2
NCT01595022 COMPLETED
Contraception
Bayer
2010-01 PHASE1
NCT00920985 COMPLETED
Contraception
Bayer
2009-06 PHASE3
NCT00764881 COMPLETED
Contraception; Libido
Bayer
2009-01 PHASE3
NCT01137708 COMPLETED
Healthy
Pfizer
2010-06 PHASE1
NCT00237042 COMPLETED
Temporomandibular Joint Disorders
University of Washington
2005-10
NCT01088178 WITHDRAWN
Contraception
United States Naval Medical Center, Portsmouth
2009-11
NCT01157754 COMPLETED
Infertility
IVI Madrid
2009-06
NCT00789802 COMPLETED
Contraception; Bleeding
Washington University School of Medicine
2008-11
NCT00455845 COMPLETED
Endometriosis; Pelvic Pain; Dysmenorrhea
Mahidol University
2007-04 PHASE3
NCT00475228 COMPLETED
Contraceptive Usage
University of Pittsburgh
2007-03 PHASE4
NCT01073904 COMPLETED
Contraceptives, Postcoital
Bayer
2009-09 PHASE1
NCT00511342 COMPLETED
Contraception
Organon and Co
2006-09 PHASE3
NCT00669396 COMPLETED
Pregnancy
University of Utah
2008-04
NCT00551616 COMPLETED
Contraception
HRA Pharma
2007-04 PHASE3
NCT01297179 COMPLETED
Healthy Volunteers; Pharmacokinetics of Mirabegron
Astellas Pharma Inc
2008-10 PHASE1
NCT01096498 COMPLETED
Contraception; Contraception, Postcoital
Bayer
2009-02 PHASE1
NCT01096485 COMPLETED
Contraception; Contraception, Postcoital
Bayer
2009-02 PHASE1
NCT00482963 COMPLETED
HIV Infections; Contraception; Pharmacokinetics
University of Colorado, Denver
2007-05 PHASE1
NCT00653159 COMPLETED
Contraception
University of Chicago
2007-07 PHASE4
NCT00185380 COMPLETED
Contraception
Bayer
2005-04 PHASE2
NCT02175394 COMPLETED
Healthy
Boehringer Ingelheim
2008-07 PHASE1
NCT00566644 TERMINATED
Endometrial Cancer; Hereditary Non-polyposis Colon Cancer (hmsh2, hmlh1, hpms1, hpms2)
St George's, University of London
2007-07 PHASE3
NCT00196313 COMPLETED
Dysmenorrhea
Duramed Research
2005-05 PHASE2
NCT00966264 COMPLETED
Menorrhagia
University of Helsinki
1994-10 PHASE3
NCT00685906 COMPLETED
Healthy
AstraZeneca
2008-04 PHASE1
NCT00476021 COMPLETED
Contraception
University of Pittsburgh
2007-05
NCT00360490 COMPLETED
Menorrhagia
Bayer
2006-07 PHASE3
NCT00621543 COMPLETED
Intrauterine Device Expulsion; Medical Abortion; Induced Abortion
Boston University
2006-03
NCT00131885 COMPLETED
Contraception
University of Utah
2005-08 PHASE4
NCT00185458 COMPLETED
Menopause
Bayer
2000-05 PHASE3
NCT01714193 COMPLETED
Healthy
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
2008-02 PHASE1
NCT01250210 COMPLETED
Ovulation Suppression
Agile Therapeutics
2007-09 PHASE2
NCT00511355 COMPLETED
Contraception
Organon and Co
2006-10 PHASE3
NCT00196365 COMPLETED
Dysmenorrhea
Duramed Research
2005-01 PHASE3
NCT00117260 WITHDRAWN
Osteopenia
Duramed Research
2005-07 PHASE3
NCT00318799 COMPLETED
Pregnancy, Unplanned
Bayer
2006-04 PHASE2
NCT01508858 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2006-11 PHASE1
NCT00490087 COMPLETED
Atypical Endometrial Polyps; Atypical Endometrial Hyperplasia
IRCCS Burlo Garofolo
1999-01 PHASE3
NCT00319163 COMPLETED
Healthy
Wyeth is now a wholly owned subsidiary of Pfizer
2006-05 PHASE1
NCT00196352 COMPLETED
Contraception
Duramed Research
2003-05 PHASE3
NCT00161681 COMPLETED
Premenstrual Syndrome
Wyeth is now a wholly owned subsidiary of Pfizer
2005-07 PHASE3
NCT00254800 COMPLETED
Type 2 Diabetes Mellitus
AstraZeneca
2005-11 PHASE1
NCT00662454 COMPLETED
Contraception; Body Weight
Oregon Health and Science University
2006-01 PHASE4
NCT00245921 COMPLETED
Contraception
Wyeth is now a wholly owned subsidiary of Pfizer
2003-02 PHASE3
NCT01044056 COMPLETED
Contraception
Organon and Co
2004-03 PHASE4
NCT00204451 COMPLETED
Contraception
University of Saskatchewan
2005-07 PHASE4
NCT00271583 COMPLETED
Emergency Contraception
University of Pittsburgh
1999-09 PHASE2; PHASE3
NCT00185224 COMPLETED
Contraception
Bayer
2005-03 PHASE2
NCT00447863 WITHDRAWN
Contraception
Wyeth is now a wholly owned subsidiary of Pfizer
2007-08 PHASE1
NCT00213096 COMPLETED
Contraception
Population Council
2003-03 PHASE2
NCT00195559 COMPLETED
Premenstrual Syndrome; Menstruation Disturbances
Wyeth is now a wholly owned subsidiary of Pfizer
2005-09 PHASE3
NCT00096694 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00206622 COMPLETED
Hot Flashes
Bayer
2004-12 PHASE4
NCT00254189 COMPLETED
Ovulation
Wyeth is now a wholly owned subsidiary of Pfizer
2002-12 PHASE2
NCT00006324 COMPLETED
HIV Infections
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1999-12
NCT00696202 COMPLETED
Medicated Intrauterine Devices; Contraception
Bayer
2003-09 PHASE4
NCT00185367 COMPLETED
Contraception
Bayer
2005-03 PHASE3
NCT00128934 COMPLETED
Menstruation Disturbances; Premenstrual Syndrome
Wyeth is now a wholly owned subsidiary of Pfizer
2005-08 PHASE3
NCT00915668 WITHDRAWN
Pharmacokinetics; Drug Interactions; Healthy
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
PHASE1
NCT00117273 COMPLETED
Healthy
Duramed Research
2005-06 PHASE3
NCT00489463 COMPLETED
Healthy
Hospital de Clinicas de Porto Alegre
2004-01
NCT00064766 UNKNOWN
Endometrial Bleeding; Periodontal Disease
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
2003-02 PHASE4
NCT00220324 COMPLETED
Contraception
Bayer
2004-02 PHASE3
NCT00520455 COMPLETED
Pregnancy
University of Washington
2004-01
NCT00248963 COMPLETED
Oral Contraceptive
Wyeth is now a wholly owned subsidiary of Pfizer
PHASE3

(data from https://clinicaltrials.gov, updated on 2026-03-04)

Check the Levonorgestrel product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Levonorgestrel, a synthetic 19-nortestosterone derivative, acts as a potent progestin agonist by selectively binding to nuclear progesterone receptors, which subsequently downregulates the secretion of hypothalamic gonadotropin-releasing hormone and prevents the pre-ovulatory luteinizing hormone surge. This targeted suppression of follicular maturation and inhibition of ovulation prevent fertilization, directly underlying its evaluation in clinical trials focused on contraception, intrauterine device insertion, and the management of irregular periods.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

Note: Technical data last updated: Sep 1, 2026.