Clinical Trials

Numerous clinical trials evaluate the clinical utility, pharmacokinetics, and safety profile of drospirenone in healthy and overweight subjects across indications including contraception, dysmenorrhea, acne vulgaris, hypertension, and postmenopausal management. Spanning Phase 1 through Phase 4, these studies encompass recruitment statuses ranging from completed and recruiting to active not recruiting, terminated, and withdrawn. The research is sponsored by major pharmaceutical corporations, including Bayer, Teva, Eli Lilly, and Boehringer Ingelheim, alongside academic institutions such as Chulalongkorn University.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07536763 NOT_YET_RECRUITING
Contraception
Dr. Hang Wun Raymond Li
 2026-07 PHASE3
NCT07340190 RECRUITING
Advanced Malignancies
Novartis Pharmaceuticals
 2026-06-12 PHASE1
NCT05303636 ACTIVE_NOT_RECRUITING
Change in Bone Mineral Density; Bone Loss
Insud Pharma
 2022-03-28 PHASE4
NCT07736261 NOT_YET_RECRUITING
Poor Ovarian Reserve; Infertility (IVF Patients)
Ahmed Saad
 2026-08 PHASE1; PHASE2
NCT07293728 NOT_YET_RECRUITING
Hypertension; Preeclampsia
Oregon Health and Science University
 2026-07 PHASE4
NCT07656792 SUSPENDED
Healthy
Boehringer Ingelheim
 2026-07-17 PHASE1
NCT05837624 RECRUITING
Ovarian Endometrioma; Endometrioma
Andrew Zakhari
 2024-12-03 PHASE4
NCT06345560 RECRUITING
Contraception
Chulalongkorn University
 2024-04-18 PHASE1; PHASE2
NCT06345586 RECRUITING
Contraception
Chulalongkorn University
 2024-04-18
NCT07242131 RECRUITING
Polycystic Ovary Syndrome (PCOS)
Ege University
 2025-12-01
NCT07318337 COMPLETED
PCOS (Polycystic Ovary Syndrome)
Mst.Sumyara Khatun
 2024-07-01
NCT07181343 COMPLETED
Psoriasis (PsO)
Hansoh BioMedical R&D Company
 2025-05-28 PHASE1
NCT06608186 COMPLETED
PCOS (Polycystic Ovary Syndrome)
Ahmed Saad
 2024-10-01 PHASE1; PHASE2
NCT05156879 UNKNOWN
Pelvic Pain
Women's Hospital School Of Medicine Zhejiang University
 2021-12-23 PHASE4
NCT06396221 COMPLETED
Ultrasound Finding: Ovulation Inhibition, Ovarian Activities; Cervical Mucus; Serum Hormonal Profile
Chulalongkorn University
 2024-05-01
NCT05461573 COMPLETED
Contraception; Change in Bone Mineral Density
Insud Pharma
 2022-08-02 PHASE3
NCT06039826 COMPLETED
Overweight
Eli Lilly and Company
 2023-09-12 PHASE1
NCT06233058 UNKNOWN
Healthy Subjects
Bio-innova Co., Ltd
 2024-03-05 PHASE1
NCT06250205 COMPLETED
Healthy Volunteers
NewAmsterdam Pharma
 2024-02-05 PHASE1
NCT06233071 UNKNOWN
Healthy Subjects
Bio-innova Co., Ltd
 2024-02-13 PHASE1
NCT05872425 COMPLETED
PCOS
Guangdong Women and Children Hospital
 2023-02-01
NCT06345560 Not yet recruiting
Contraception
Chulalongkorn University
 2024-04 Phase 1|Phase 2
NCT05934942 TERMINATED
Healthy
Boehringer Ingelheim
 2023-09-08 PHASE1
NCT05985590 COMPLETED
Healthy Volunteers
Bristol-Myers Squibb
 2023-08-18 PHASE1
NCT05675644 UNKNOWN
Contraception
University of Colorado, Denver
 2023-02 PHASE2
NCT04792385 COMPLETED
Safety
Estetra
 2020-12-28 PHASE3
NCT05934942 Terminated
Healthy
Boehringer Ingelheim
 2023-09-08 Phase 1
NCT06039826 Active not recruiting
Overweight
Eli Lilly and Company
 2023-09-12 Phase 1
NCT06324851 COMPLETED
Endometrial Polyp; Endometrial Diseases
University of Palermo
 2023-01-01 PHASE4
NCT06316180 COMPLETED
Endometrial Polyp; Endometrial Diseases
University of Palermo
 2023-01-01 PHASE4
NCT05706753 COMPLETED
Healthy Female
Janssen Pharmaceutica N.V., Belgium
 2023-01-25 PHASE1
NCT04831151 UNKNOWN
Polycystic Ovary Syndrome
Inonu University
 2021-03-01
NCT04278755 TERMINATED
Bulimia Nervosa; Binge Eating; Eating Disorders; Binge-Eating Disorder
University of North Carolina, Chapel Hill
 2020-09-24 PHASE2
NCT03890341 WITHDRAWN
Healthy
Janssen Research & Development, LLC
 2021-06-01 PHASE1
NCT04792385 Completed
Safety
Estetra
 2020-12-28 Phase 3
NCT02757469 UNKNOWN
Primary Ovarian Insufficiency; Menopause, Premature
Navy General Hospital, Beijing
 2016-05
NCT03418363 COMPLETED
Contraceptive Usage; Coagulation
Oregon Health and Science University
 2018-01-16 PHASE4
NCT02817841 COMPLETED
Contraception
Estetra
 2016-08-30 PHASE3
NCT03512860 COMPLETED
Contraception
Estetra
 2018-04-12 PHASE1
NCT03074045 COMPLETED
Contraception
Bayer
 2017-03-13 PHASE3
NCT03353857 COMPLETED
Biological Availability
Bayer
 2017-11-29 PHASE1
NCT02710708 COMPLETED
Contraception
Bayer
 2016-05-27 PHASE4
NCT03091595 COMPLETED
Prevention of Pregnancy
Estetra
 2017-02-07 PHASE2
NCT02817828 COMPLETED
Contraception
Estetra
 2016-06 PHASE3
NCT02957630 COMPLETED
Contraception; Liver Metabolism; Hemostasis Parameter
Estetra
 2016-09 PHASE1; PHASE2
NCT02269241 COMPLETED
Contraception
Laboratories Leon Farma, S.A.
 2014-10-09 PHASE3
NCT02617537 WITHDRAWN
Dysmenorrhea
Bayer
 2016-01 PHASE3
NCT03111511 COMPLETED
Healthy
Janssen Sciences Ireland UC
 2017-03-27 PHASE1
NCT03126097 TERMINATED
Healthy
Janssen Research & Development, LLC
 2017-04-13 PHASE1
NCT02885454 COMPLETED
Healthy
Janssen Research & Development, LLC
 2016-08 PHASE1
NCT02874248 COMPLETED
Contraception
Estetra
 2016-05 PHASE1
NCT03124524 COMPLETED
Primary Dysmenorrhea
Adana Numune Training and Research Hospital
 2015-01-15 PHASE4
NCT02855294 COMPLETED
Joint Stabilioty
Cairo University
 2015-01 PHASE4
NCT01608698 UNKNOWN
Body Weight Changes
Mahidol University
 2012-06 PHASE4
NCT02852681 COMPLETED
Contraception
Estetra
 2015-08 PHASE1
NCT00640224 COMPLETED
Polycystic Ovary Syndrome
Silva Arslanian
 2005-03 PHASE4
NCT02089620 COMPLETED
Premenstrual Syndrome
Beni-Suef University
 2014-05 PHASE3
NCT02384408 COMPLETED
Menopause
Universidade do Vale do Sapucai
 2014-11 PHASE4
NCT02027337 UNKNOWN
Polycystic Ovarian Syndrome; Hyperandrogenism; Menstrual Irregularities
Tyumen State Medical Academy
 2013-12 PHASE4
NCT01360996 COMPLETED
Polycystic Ovary Syndrome
Woman's
 2011-08 PHASE4
NCT01902264 COMPLETED
Contraception
Bayer
 2013-08 PHASE3
NCT01892904 COMPLETED
Dysmenorrhea
Bayer
 2013-07 PHASE3
NCT01697111 COMPLETED
Endometriosis
Bayer
 2012-10 PHASE3
NCT01805817 WITHDRAWN
Contraceptive Methods Comparison
Istanbul Training and Research Hospital
 2012-12 PHASE4
NCT02342093 COMPLETED
Blood Pressure; Contraception
University of Sao Paulo
 2011-01 PHASE4
NCT01254292 COMPLETED
Contraception
Bayer
 2011-01-06 PHASE3
NCT00442689 COMPLETED
Polycystic Ovary Syndrome; Metabolic Syndrome
Northwestern University
 2006-07
NCT01257984 COMPLETED
Contraception
Bayer
 2010-12 PHASE3
NCT01603745 UNKNOWN
Polycystic Ovary Syndrome
Catholic University of the Sacred Heart
 2012-04 PHASE1
NCT01590849 UNKNOWN
Contraceptive Affecting the Autonomic Nervous System; Contraceptive Affecting Blood Pressure
Instituto do Coracao
 2011-01 PHASE3
NCT00722761 COMPLETED
Acne Vulgaris
Massachusetts General Hospital
 2009-04 PHASE3
NCT01291004 COMPLETED
Follicle Development; Ovarian Follicle; Follicle Count; Follicle Size; Oral Contraceptive
Teva Branded Pharmaceutical Products R&D, Inc.
 2011-01-31 PHASE1
NCT01482338 COMPLETED
Premenstrual Syndrome
Chulalongkorn University
 2011-06 PHASE4
NCT01109979 COMPLETED
Cardiovascular Diseases
Brigham and Women's Hospital
 2009-12 PHASE4
NCT00722800 TERMINATED
Hidradenitis Suppurativa
Massachusetts General Hospital
 2008-10 PHASE2
NCT01076582 COMPLETED
Oral Contraceptive
Bayer
 2010-04 PHASE3
NCT01519401 COMPLETED
Polycystic Ovary Syndrome; Estro-progestin Drugs
Catholic University of the Sacred Heart
 2010-02
NCT01581814 COMPLETED
Polycystic Ovary Syndrome
Catholic University of the Sacred Heart
 2008-10 PHASE3
NCT01459445 UNKNOWN
Polycystic Ovary Syndrome; Endothelial Dysfunction
Iuliu Hatieganu University of Medicine and Pharmacy
 2011-02
NCT00633360 COMPLETED
Premenstrual Syndrome; Depression
Massachusetts General Hospital
 2008-02
NCT01432028 COMPLETED
Postmenopause
Denusa Wiltgen
 2007-03
NCT01195974 TERMINATED
Infection, Human Immunodeficiency Virus; HIV Infections
ViiV Healthcare
 2010-09-14 PHASE1
NCT00824187 COMPLETED
Premenstrual Dysphoric Disorder ( PMDD)
Bayer
 2009-01 PHASE3
NCT00819312 COMPLETED
Contraception
Bayer
 2008-12 PHASE3
NCT00089414 TERMINATED
Premenstrual Syndrome; PMS; Premenstrual Dysphoric Disorder; PMDD; Depression
National Institute of Mental Health (NIMH)
 2004-07 PHASE2
NCT00818519 COMPLETED
Acne Vulgaris
Bayer
 2008-12 PHASE3
NCT00569244 COMPLETED
Primary Dysmenorrhea
Bayer
 2007-12 PHASE3
NCT00915174 COMPLETED
Healthy
Merz Pharmaceuticals GmbH
 2009-06 PHASE1
NCT00567164 COMPLETED
Contraception; Ovulation Inhibition; Contraceptives, Oral
Bayer
 2007-10 PHASE3
NCT00785317 UNKNOWN
Hormone Replacement Therapy
Karolinska Institutet
 2008-11 PHASE4
NCT00522873 COMPLETED
Postmenopause
Bayer
 2007-08 PHASE3
NCT00653614 COMPLETED
Contraceptive, Oral, Hormonal
Bayer
 2008-03 PHASE2
NCT00461305 COMPLETED
Dysmenorrhea
Bayer
 2007-02 PHASE2; PHASE3
NCT00511797 COMPLETED
Dysmenorrhea
Bayer
 2007-07 PHASE2; PHASE3
NCT00266032 COMPLETED
Contraception
Bayer
 2005-12 PHASE3
NCT00631124 COMPLETED
Contraception
Bayer
 2008-02 PHASE2
NCT00745901 COMPLETED
Contraception
Ortho-McNeil Janssen Scientific Affairs, LLC
 2008-05 PHASE4
NCT00446199 COMPLETED
Vasomotor Symptoms; Hot Flashes
Bayer
 2007-03 PHASE3
NCT00420342 COMPLETED
Postmenopause; Hypertension; Pre-Hypertension
Bayer
 2007-01 PHASE2
NCT00468481 COMPLETED
Neural Tube Defects; Contraception; Oral Contraceptives (OC)
Bayer
 2007-04 PHASE3
NCT00413062 COMPLETED
Contraception
Organon and Co
 2006-06 PHASE3
NCT00511199 COMPLETED
Contraception
Organon and Co
 2006-05-01 PHASE3
NCT00511433 COMPLETED
Contraception
Organon and Co
 2006-10 PHASE3
NCT01258660 COMPLETED
Contraception
Bayer
 2006-12 PHASE1
NCT00356447 COMPLETED
Vasomotor Symptoms
Bayer
 2006-05 PHASE3
NCT00593294 COMPLETED
Polycystic Ovary Syndrome
Federico II University
 2006-01 PHASE4
NCT01253187 COMPLETED
Contraception
Bayer
 2006-10 PHASE1
NCT01253174 COMPLETED
Contraception
Bayer
 2006-08 PHASE1
NCT01182194 COMPLETED
Healthy
Teva Pharmaceuticals USA
 2006-06 PHASE1
NCT01182207 COMPLETED
Healthy
Teva Pharmaceuticals USA
 2006-07 PHASE1
NCT00185419 COMPLETED
Contraception
Bayer
 2003-11 PHASE3
NCT00102141 COMPLETED
Hypertension; Postmenopause
Bayer
 2004-04 PHASE3
NCT00651469 COMPLETED
Acne Vulgaris
Bayer
 2003-01 PHASE3
NCT00651599 COMPLETED
Vasomotor Symptoms
Bayer
 2004-07 PHASE3
NCT00367276 COMPLETED
Healthy
Bayer
 2002-12 PHASE3
NCT01511822 COMPLETED
PCOS; Polycystic Ovary Syndrome
AGUNCO Obstetrics and Gynecology Centre
 PHASE4
NCT00656981 COMPLETED
Acne Vulgaris
Bayer
 2003-01 PHASE3
NCT00185484 COMPLETED
Contraception
Bayer
 2004-03 PHASE3

(data from https://clinicaltrials.gov, updated on 2026-04-27)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Drospirenone selectively binds to progesterone and mineralocorticoid receptors as a synthetic progestin, thereby suppressing luteinizing hormone secretion and inhibiting downstream aldosterone signaling. This biochemical blockade prevents ovulation, reduces systemic fluid retention, and modulates endometrial proliferation, providing therapeutic efficacy in oral contraception, dysmenorrhea management, and the control of acne vulgaris and hypertension.

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>).

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