Clinical Trials

Numerous clinical trials evaluate etonogestrel across Phase 1 through Phase 4 as well as non-interventional studies, primarily investigating its utility in contraception, dysmenorrhea, abnormal uterine bleeding, and drug interactions with antiretrovirals. Sponsored by both academic institutions and pharmaceutical entities, these protocols span completed, recruiting, withdrawn, and upcoming studies. Overall, these investigations reflect a continuous effort to characterize etonogestrel's safety, efficacy, and pharmacokinetic profiles.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06162611 RECRUITING
Emergency Contraception
Lori Gawron
 2023-11-06 PHASE4
NCT05237141 RECRUITING
Contraception
University of Colorado, Denver
 2022-04-01 PHASE4
NCT03307863 SUSPENDED
Contraception; Drug Interactions
University of Sao Paulo
 2017-11-01 PHASE4
NCT07201402 RECRUITING
Contraception
Yale University
 2026-05-08 PHASE2
NCT05174884 ACTIVE_NOT_RECRUITING
Contraception
FHI 360
 2023-12-13 PHASE1
NCT05044962 RECRUITING
HIV Infections; Contraception; Drug-drug Interaction
University of Alabama at Birmingham
 2021-11-26
NCT05760144 RECRUITING
Contraception
Oregon Health and Science University
 2023-07-01 EARLY_PHASE1
NCT05791799 UNKNOWN
Systemic Lupus Erythematosus
Sixth Affiliated Hospital, Sun Yat-sen University
 2023-04-01 PHASE2; PHASE3
NCT04257500 COMPLETED
Polycystic Ovary Syndrome
Andrea Roe, MD, MPH
 2020-09-03 PHASE4
NCT06775626 SUSPENDED
Menstrual Symptoms
Maíta Poli de Araújo
 2025-04-01 EARLY_PHASE1
NCT04626596 COMPLETED
Contraception
Organon and Co
 2020-11-19 PHASE3
NCT05156658 WITHDRAWN
HIV-1-infection
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
 2024-01-01 PHASE4
NCT03978598 COMPLETED
Contraception
University of New Mexico
 2019-06-03 PHASE4
NCT04933240 WITHDRAWN
Vaginal Bleeding
Virginia Commonwealth University
 2022-05 PHASE4
NCT06334315 Not yet recruiting
Contraception|Pharmacogenomic Drug Interaction
Yale University|Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
 2024-05 Phase 4
NCT05227456 WITHDRAWN
Abnormal Uterine Bleeding; Dysmenorrhea
Saskatchewan Health Authority - Regina Area
 2022-07-01 PHASE2
NCT04423055 COMPLETED
Contraception
University of California, Davis
 2020-08-13 PHASE4
NCT04669678 COMPLETED
HIV Infections; Contraception; Drug-drug Interaction
University of Alabama at Birmingham
 2021-11-17 PHASE4
NCT04882137 WITHDRAWN
Contraceptive Usage
Nemours Children's Clinic
 2023-09-01
NCT05994599 COMPLETED
Healthy Women; Female; Contraception
Evestra Inc.
 2023-07-29 PHASE1
NCT04882137 Withdrawn
Contraceptive Usage
Nemours Children''s Clinic|Merck Sharp & Dohme LLC
 2023-09-01 Not Applicable
NCT05040282 COMPLETED
Contraception
Assiut University
 2021-10-01
NCT04047875 COMPLETED
Breakthrough Bleeding
University of Sao Paulo
 2020-09-15 PHASE4
NCT05360550 COMPLETED
Pregnancy Prevention
Lupin Research Inc
 2022-07-05 PHASE2
NCT04814927 COMPLETED
Mucosal Inflammation; Contraceptive; Complications, Intrauterine
Eastern Virginia Medical School
 2021-03-01 PHASE4
NCT04291001 COMPLETED
Contraception
University of Utah
 2020-09-04 EARLY_PHASE1
NCT05360576 COMPLETED
Pregnancy Prevention
Lupin Research Inc
 2022-02-24 PHASE2
NCT05360550 Completed
Pregnancy Prevention
Lupin Research Inc
 2022-07-05 Phase 2
NCT04463680 COMPLETED
Contraception; Tuberculosis
University of Colorado, Denver
 2020-09-23 PHASE4
NCT04463693 COMPLETED
Contraception
University of Colorado, Denver
 2020-10-14 PHASE4
NCT05040282 Completed
Contraception
Assiut University
 2021-10-01 Not Applicable
NCT03335163 COMPLETED
Migraine; Migraine;Menstrual; Contraception
University of Colorado, Denver
 2018-03-15 PHASE1
NCT02866279 COMPLETED
Contraception; Breastfeeding; Postpartum Contraception
Montefiore Medical Center
 2016-11
NCT02267616 COMPLETED
Contraception
Indiana University
 2011-12
NCT03282799 COMPLETED
HIV/AIDS; Contraception
Catherine Anne Chappell
 2019-02-19 PHASE2
NCT02986204 COMPLETED
Women With an ENG Contraceptive Implant
University of California, Los Angeles
 2017-01
NCT01658995 COMPLETED
ESI-related Bleeding
Petra M. Casey
 2012-09-13 PHASE3
NCT02357368 COMPLETED
HIV; Contraception
Lisa Haddad
 2015-02 PHASE4
NCT02866643 COMPLETED
Postpartum Contraception; Family Planning
Stanford University
 2016-10-28 PHASE3
NCT03589040 UNKNOWN
HIV; Contraception
Makerere University
 2018-09-25 PHASE2
NCT03656289 WITHDRAWN
Contraception
University of Colorado, Denver
 2019-01-01 PHASE1
NCT02594462 COMPLETED
Sickle Cell Disease
University of Sao Paulo
 2015-01 PHASE4
NCT03120728 UNKNOWN
Emergency Contraception; Healthy, Reproductive Age Women
University of Southern California
 2017-07-10 PHASE4
NCT03353012 COMPLETED
Breastfeeding; Post Partum
Chulalongkorn University
 2018-01-01 PHASE4
NCT01980342 TERMINATED
Drug Interaction
Johns Hopkins University
 2014-10 PHASE4
NCT05174195 TERMINATED
Contraception; Progestogen Adverse Reaction
University Hospital, Geneva
 2016-08-15
NCT03118297 COMPLETED
Contraception; Bleeding
Washington University School of Medicine
 2017-05-01 PHASE3
NCT02480647 COMPLETED
Endometriosis
University of Campinas, Brazil
 2016-05 PHASE4
NCT02852265 COMPLETED
Contraception
University of California, Davis
 2016-09-15 PHASE4
NCT02353247 COMPLETED
Etonogestrel Contraceptive Implant, Bothersome Bleeding
Norton Healthcare
 2015-08
NCT02616146 TERMINATED
Contraception
Organon and Co
 2015-12-01 PHASE3
NCT02524288 TERMINATED
Contraception
Organon and Co
 2015-08-31 PHASE3
NCT02668783 TERMINATED
Moderate to Severe Primary Dysmenorrhea
Organon and Co
 2016-02-11 PHASE3
NCT02469454 COMPLETED
Contraception; Newborn; Child Development; Growth
University of Sao Paulo
 2015-06 PHASE4
NCT02082652 COMPLETED
HIV; Contraception
University of Pittsburgh
 2014-10 PHASE4
NCT02070692 COMPLETED
Menstruation Disturbances
Oregon Health and Science University
 2014-02 PHASE4
NCT01767285 COMPLETED
Continuation Rate of Contraceptive Implant
Duke University
 2013-01 PHASE4
NCT01666912 COMPLETED
Adolescence; Contraception; Postpartum
University of North Carolina, Chapel Hill
 2012-08 PHASE4
NCT02416687 COMPLETED
Contraception
University of Sao Paulo
 2014-03 PHASE4
NCT01968135 COMPLETED
Uterine Hemorrhage; Contraception
University of Colorado, Denver
 2013-10 PHASE2
NCT01816932 COMPLETED
Contraception
Case Western Reserve University
 2013-06
NCT01709318 COMPLETED
Contraception
Organon and Co
 2012-12-12 PHASE2
NCT01670656 COMPLETED
Dysmenorrhea
Organon and Co
 2013-01-21 PHASE2
NCT03585504 COMPLETED
Contraceptive Usage
Medical University of South Carolina
 2010-01 PHASE3
NCT01490190 COMPLETED
Contraception
Organon and Co
 2011-12-26 PHASE4
NCT01438736 UNKNOWN
Bleeding
VL-Medi Oy
 2011-09 PHASE4
NCT01448291 UNKNOWN
Vaginosis, Bacterial
Eastern Virginia Medical School
 2011-10 PHASE4
NCT01388582 COMPLETED
Underweight
University of Campinas, Brazil
 2011-04 PHASE4
NCT01087879 COMPLETED
Contraception
University of Oulu
 2007-10
NCT00967746 COMPLETED
Contraception
Organon and Co
 2009-11 PHASE2
NCT00620035 COMPLETED
Contraception
Organon and Co
 2007-03 PHASE3
NCT00847587 COMPLETED
Complications; Contraceptive; Female Lactation
University of Utah
 2009-01 PHASE4
NCT00620464 COMPLETED
Contraception
Organon and Co
 2005-05 PHASE3
NCT00651807 TERMINATED
Benign Prostatic Hyperplasia (BPH)
Organon and Co
 2008-03 PHASE2
NCT00612508 COMPLETED
Contraceptive Usage; Vaginal Epithelial Disruption
Oregon Health and Science University
 2007-05
NCT00828542 COMPLETED
Breastfeeding; Contraception
University of Sao Paulo
 2007-07
NCT00403793 COMPLETED
Contraception
Organon and Co
 2003-10 PHASE2
NCT00269620 COMPLETED
Contraception
University of Pittsburgh
 2005-06 PHASE4
NCT00725413 COMPLETED
Contraception
Organon and Co
 2001-11 PHASE4

(data from https://clinicaltrials.gov, updated on 2026-06-02)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Etonogestrel binds to cytoplasmic progesterone receptors in reproductive tissues, inducing receptor-mediated gene transcription that suppresses gonadotropin-releasing hormone activity and the pre-ovulatory luteinizing hormone surge. This central inhibition prevents follicular maturation and ovulation while increasing cervical mucus viscosity, thereby providing effective contraception, pregnancy prevention, and therapeutic relief for abnormal uterine bleeding and dysmenorrhea evaluated in clinical trials.

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.