Clinical Trials

Dienogest has been investigated across numerous clinical trials spanning early to late development phases to evaluate its therapeutic efficacy in gynecological and reproductive conditions, notably endometriosis-associated pelvic pain, oral contraception, uterine leiomyomas, adenomyosis, and infertility management. Sponsored by both major pharmaceutical entities and academic institutions, these studies encompass completed, active, and terminated protocols evaluating patient satisfaction, pain reduction, and pharmacodynamics.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07164183 RECRUITING
Endometriosis
Alcea
 2025-09-11 PHASE3
NCT07770594 COMPLETED
Endometrioma
Mst.Sumyara Khatun
 2025-04-17
NCT05697471 UNKNOWN
Endometriosis
Far Eastern Memorial Hospital
 2023-02-25 PHASE3
NCT06543550 UNKNOWN
Endometriosis
Bio Meds Pharmaceutica Ltda
 2024-07-30 PHASE4
NCT06719934 NOT_YET_RECRUITING
Adenomyosis
Al-Azhar University
 2025-01-01 PHASE1
NCT05937490 UNKNOWN
Adenomyosis
Azienda Ospedaliero-Universitaria di Modena
 2023-03-27 PHASE4
NCT06396208 COMPLETED
Ultrasound Finding: Ovulation Inhibition, Ovarian Activities; Cervical Mucus; Serum Hormonal Profile
Chulalongkorn University
 2024-05-09
NCT06115408 COMPLETED
Uterine Leiomyoma
Ain Shams University
 2023-09-01 PHASE2; PHASE3
NCT06145438 COMPLETED
Endometriosis Ovary
Universitas Diponegoro
 2023-09-04 PHASE3
NCT06324851 COMPLETED
Endometrial Polyp; Endometrial Diseases
University of Palermo
 2023-01-01 PHASE4
NCT06316206 COMPLETED
Endometrial Polyp; Endometrial Diseases
University of Palermo
 2023-01-01 PHASE4
NCT03945513 COMPLETED
Contraception
Insud Pharma
 2019-12-03 PHASE3
NCT05476172 COMPLETED
Endometriosis
Uludag University
 2021-04-01
NCT03142035 UNKNOWN
Endometriosis
American University of Beirut Medical Center
 2017-10-22
NCT04808843 Active not recruiting
Endometriosis Associated Pelvic Pain
Bayer
 2022-05-13 --
NCT05332106 COMPLETED
Bioequivalence
Laboratorios Andromaco S.A.
 2022-03-12 PHASE1
NCT02427334 UNKNOWN
Premenstrual Syndrome
Cairo University
 2015-04 PHASE3
NCT05013242 UNKNOWN
Endometriosis
Mansoura University
 2020-12-25 PHASE4
NCT04256200 UNKNOWN
Endometriosis
American University of Beirut Medical Center
 2017-02-07 PHASE2; PHASE3
NCT04901377 Completed
Oral Contraception
Bayer
 2021-06-24 --
NCT05272930 Completed
Fibromyalgia|Endometriosis Ovary|Dienogest
Gaziosmanpasa Research and Education Hospital
 2021-06-30 --
NCT03890042 COMPLETED
Adenomyosis
Assiut University
 2019-03-01
NCT04374006 COMPLETED
Endometriosis; Peritoneum; Endometriosis
Indonesia University
 2019-11-01 EARLY_PHASE1
NCT04230083 COMPLETED
Bioequivalence
Laboratorios Andromaco S.A.
 2019-12-07 PHASE1
NCT03654144 UNKNOWN
Adenomyosis
Assiut University
 2018-11 PHASE4
NCT04193852 COMPLETED
Bioequivalence
Laboratorios Andromaco S.A.
 2019-11-09 PHASE1
NCT04500743 COMPLETED
IVF; Endometriosis; Pregnancy Rate; Progestins; GnRH-analogue
National Research Centre, Egypt
 2018-08-01
NCT03789123 UNKNOWN
Ovarian Reserve
Bagcilar Training and Research Hospital
 2019-01-01 PHASE4
NCT03172533 TERMINATED
Anorexia Nervosa
University of Erlangen-Nürnberg Medical School
 2016-03-15 PHASE2
NCT02352090 COMPLETED
Contraception
Helsinki University Central Hospital
 2015-04-01 PHASE4
NCT03353857 COMPLETED
Biological Availability
Bayer
 2017-11-29 PHASE1
NCT02728245 WITHDRAWN
Ovarian Reserve; Endometriosis
Seoul National University Hospital
 2017-10 PHASE2
NCT02400801 COMPLETED
Endometriosis; Infertility
Universitaire Ziekenhuizen KU Leuven
 2013-06
NCT02599077 SUSPENDED
Endometriosis
Fundación Santa Fe de Bogota
 2015-11 PHASE2; PHASE3
NCT02575248 UNKNOWN
Infertility
Ain Shams University
 2014-10 PHASE4
NCT02440750 UNKNOWN
Uterine Fibroids
University of Cagliari
 2016-06 PHASE4
NCT02385448 UNKNOWN
Endometriosis
The University of Hong Kong
 2015-02 PHASE4
NCT01738724 TERMINATED
Uterine Leiomyoma
University of Sao Paulo
 2012-01 PHASE4
NCT03124524 COMPLETED
Primary Dysmenorrhea
Adana Numune Training and Research Hospital
 2015-01-15 PHASE4
NCT01638923 COMPLETED
Metrorrhagia
Bayer
 2012-06 PHASE3
NCT01822080 COMPLETED
Endometriosis
Bayer
 2013-03 PHASE3
NCT01557023 WITHDRAWN
Metrorrhagia
Eurofarma Laboratorios S.A.
 2013-07-01 PHASE3
NCT01638910 COMPLETED
Contraception
Bayer
 2012-06 PHASE3
NCT01697111 COMPLETED
Endometriosis
Bayer
 2012-10 PHASE3
NCT01283724 COMPLETED
Endometriosis
Bayer
 2011-03 PHASE2
NCT01221831 COMPLETED
Contraception
Estetra
 2010-09 PHASE2
NCT00754065 COMPLETED
Contraception
Bayer
 2008-09-08 PHASE3
NCT00909857 COMPLETED
Primary Dysmenorrhea
Bayer
 2009-04 PHASE3
NCT00764881 COMPLETED
Contraception; Libido
Bayer
 2009-01 PHASE3
NCT01600274 COMPLETED
Focus: Bioequivalence
Pharbil Waltrop GmbH
 2010-01
NCT00941057 COMPLETED
Pharmacology, Clinical
Bayer
 2009-09 PHASE1
NCT00754871 COMPLETED
Pharmacodynamics
Bayer
 2008-09 PHASE1
NCT00307801 COMPLETED
Metrorrhagia
Bayer
 2006-02 PHASE3
NCT00293059 COMPLETED
Metrorrhagia
Bayer
 2005-12 PHASE3
NCT00471991 COMPLETED
Oral Contraceptive
Bayer
 2007-04 PHASE2
NCT00805415 COMPLETED
Ovulation Inhibition
Bayer
 2003-03 PHASE2
NCT00302666 COMPLETED
Oral Contraceptive
Bayer
 2003-06 PHASE3
NCT00335218 COMPLETED
Healthy; Postmenopause
Bayer
 2002-07 PHASE4

(data from https://clinicaltrials.gov, updated on 2025-09-18)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Dienogest selectively binds to and activates the progesterone receptor, suppressing gonadotropin secretion and downregulating local estrogenic signaling pathways in target tissues. This antiandrogenic progestational activity inhibits ectopic endometrial proliferation and suppresses ovulation, directly accounting for its clinical efficacy in managing endometriosis-associated pelvic pain and providing reliable oral contraception.

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.