Drugs / drospirenone
last change Sep 2026 re-read 9 days ago

drospirenone

Developed for
polycystic ovary syndrome · dysmenorrhea · acne · premenstrual dysphoric disorder · anovulation · depressive disorder · ovarian endometriosis · adenomyosis
+16 more · binge eating disorder · endometrial polyp · endometriosis · essential hypertension · hidradenitis suppurativa · hypertensive disorder · menstrual disorder · pelvis syndrome · preeclampsia · premature menopause · premenstrual tension · primary dysmenorrhea · sexual disorder · vasomotor rhinitis · cardiovascular disorder · uterine anomalies
Investigated by
Bayer · Estetra · Chulalongkorn University · Janssen Research & Development, LLC · Vertex Pharmaceuticals Incorporated · Bio-innova Co., Ltd
+57 more · Chemo Research · Insud Pharma · Massachusetts General Hospital · PRA Health Sciences · Ahmed Saad · Ain Shams Maternity Hospital · Andrew Zakhari · Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma · Boehringer Ingelheim · Bristol Myers Squibb Company (BMS) · Bristol-Myers Squibb · Chemo France · Diagnostic Cytology Laboratory · Dr. Hang Wun Raymond Li · Ege University · Eli Lilly and Company · Foundation of Hope, North Carolina · Fudan University · Grupo CINUSA (Centros de Investigación en Nutrición y Salud S.L.) · Hamilton Academic Health Sciences Organization · Hansoh BioMedical R&D Company · Hyundai Pharm · Inonu University · Iuliu Hatieganu University of Medicine and Pharmacy · Janssen Pharmaceutica N.V., Belgium · Janssen Sciences Ireland UC · Karolinska Institutet · Laboratories Leon Farma, S.A. · Laboratorium für Klinische Forschung · Mahidol University · Margan Biotech · McMaster University · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · National Institute of Mental Health (NIMH) · Navy General Hospital, Beijing · NewAmsterdam Pharma · Northwestern University · Novartis Pharmaceuticals · Novum · Oregon Health and Science University · Patty Brisben Foundation For Women's Sexual Health · Peking Union Medical College · Peking Union Medical College Hospital · Quotient Sciences · Servier · St. Joseph's Healthcare Hamilton · The Family Planning Association of Hong Kong · Tyumen State Medical Academy · University of Athens · University of California, San Diego · University of California, San Francisco · University of Colorado, Denver · University of North Carolina, Chapel Hill · University of Palermo · University of Roma La Sapienza · Woman's · Wright State University

Regulatory milestones approvals, filings & regulatory actions · 3 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed Japan (PMDA) — contraception 2024-06-24

“LF111(一般名:ドロスピレノン、以下「本剤」)について、避 妊を適応症として本日付けで製造販売承認申請を行いました” aska-pharma.co.jp ↗

Approved EU (EMA) Lydisilka — 2021-05-19 europa.eu ↗
Approved US (FDA) YASMIN — 2001-05-11 fda.gov ↗

Trials 87 · started per year

today
US approved 2001
EU approved 2021
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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT03037944 Mar 2016 → Dec 2017 adenomyosis Ain Shams Maternity Hospital Unknown No outcome recorded
Phase 121 trials
Phase 1 NCT07792408 Sep 2026 → Mar 2027 expected autosomal dominant polycystic kidney disease Vertex Pharmaceuticals Incorporated Recruiting No outcome recorded
Phase 1 NCT07340190 Jun 2026 → Mar 2028 expected cancer Novartis Pharmaceuticals Recruiting No outcome recorded
Phase 1 NCT07235774 Nov 2025 → Mar 2026 — Servier Completed No outcome recorded
Phase 1 NCT07074327 Jul 2025 → Feb 2026 autosomal dominant polycystic kidney disease Vertex Pharmaceuticals Incorporated Completed No outcome recorded
Phase 1 NCT07181343 May → Jun 2025 psoriasis Hansoh BioMedical R&D Company Completed No outcome recorded
Phase 1 NCT06820307 Feb → Apr 2025 — Vertex Pharmaceuticals Incorporated Completed No outcome recorded
Phase 1 NCT06233058 Mar → Apr 2024 — Bio-innova Co., Ltd Unknown No outcome recorded
Phase 1 NCT06233071 Feb → Apr 2024 — Bio-innova Co., Ltd Unknown No outcome recorded
Phase 1 NCT06250205 Feb → Apr 2024 — NewAmsterdam Pharma Completed No outcome recorded
Phase 1 NCT06039826 Sep 2023 → Jul 2024 obesity disorder Eli Lilly and Company Completed No outcome recorded
Phase 1/23 trials
Phase 1/2 NCT06608186 Oct 2024 → Jan 2025 polycystic ovary syndrome Ahmed Saad Completed No outcome recorded
Phase 1/2 NCT06345560 Apr 2024 → Jul 2026 overdue — Chulalongkorn University Recruiting No outcome recorded
Phase 1/2 NCT02957630 Sep 2016 → Oct 2017 — Estetra Completed No outcome recorded
Phase 29 trials · 1 missed
Phase 2 NCT05098574 Feb 2023 → Apr 2024 bipolar disorder, premenstrual dysphoric disorder St. Joseph's Healthcare Hamilton Completed No outcome recorded
Phase 2 NCT05675644 Feb → Dec 2023 — University of Colorado, Denver Unknown No outcome recorded
Phase 2 NCT04278755 Sep 2020 → May 2022 binge eating disorder, bulimia nervosa University of North Carolina, Chapel Hill Terminated No outcome recorded Stop: Enrollment
Phase 2 NCT00722800 Oct 2008 → Dec 2011 hidradenitis suppurativa Massachusetts General Hospital Terminated No outcome recorded Stop: Enrollment
Phase 2 NCT00653614 Mar 2008 → Jun 2009 — Bayer Completed No outcome recorded
Phase 2 NCT00631124 Feb → Oct 2008 — Bayer Completed No outcome recorded
Phase 2 NCT00420342 Jan 2007 → Sep 2008 hypertensive disorder Bayer Completed Missed primary
Phase 2 NCT00089414 Jul 2004 → Jun 2010 depressive disorder, premenstrual dysphoric disorder National Institute of Mental Health (NIMH) Terminated No outcome recorded
Phase 2 NCT00673686 May 2004 → Feb 2005 — Bayer Completed No outcome recorded
Phase 2/32 trials · 1 met primary
Phase 2/3 NCT00511797 Jul 2007 → Jan 2009 dysmenorrhea Bayer Completed Met primary
Phase 2/3 NCT00461305 Feb 2007 → Jan 2009 dysmenorrhea Bayer Completed No outcome recorded
Phase 327 trials · 8 met primary
Phase 3 NCT07536763 Jul 2026 → Jun 2029 expected — Dr. Hang Wun Raymond Li Not yet recruiting No outcome recorded
Phase 3 NCT05461573 Aug 2022 → Aug 2024 — Insud Pharma Completed No outcome recorded
Phase 3 NCT04792385 Dec 2020 → Nov 2023 — Estetra Completed No outcome recorded
Phase 3 NCT03843736 Feb 2019 → Jun 2020 polycystic ovary syndrome Peking Union Medical College Hospital Unknown No outcome recorded
Phase 3 NCT02817841 Aug 2016 → Oct 2018 — Estetra Completed No outcome recorded
Phase 3 NCT02817828 Jun 2016 → Apr 2018 — Estetra Completed No outcome recorded
Phase 3 NCT02617537 Jan 2016 → Sep 2017 dysmenorrhea Bayer Withdrawn No outcome recorded
Phase 3 NCT02269241 Oct 2014 → Oct 2017 — Laboratories Leon Farma, S.A. Completed Met primary
Phase 3 NCT01892904 Jul 2013 → Jan 2015 dysmenorrhea Bayer Completed No outcome recorded
Phase 3 NCT01331655 Apr 2013 → Nov 2014 — Bayer Withdrawn No outcome recorded
Phase 414 trials · 1 met primary
Phase 4 NCT07293728 Jul → Dec 2026 expected preeclampsia Oregon Health and Science University Not yet recruiting No outcome recorded
Phase 4 NCT05837624 Dec 2024 → Nov 2026 expected ovarian endometriosis Andrew Zakhari Recruiting No outcome recorded
Phase 4 NCT06324851 Jan → Aug 2023 endometrial polyp University of Palermo Completed No outcome recorded
Phase 4 NCT05303636 Mar 2022 → Dec 2027 expected disease of bone structure Insud Pharma Active not recruiting No outcome recorded
Phase 4 NCT04965116 Oct 2021 → Nov 2022 — University of California, San Diego Completed No outcome recorded
Phase 4 NCT05340634 Apr 2020 → Feb 2022 polycystic ovary syndrome Margan Biotech Completed No outcome recorded
Phase 4 NCT02710708 May 2016 → Jul 2018 — Bayer Completed No outcome recorded
Phase 4 NCT02237131 Apr 2014 → Apr 2015 dysmenorrhea, ovarian endometriosis, pelvis syndrome University of Athens Unknown No outcome recorded
Phase 4 NCT02027337 Dec 2013 → Mar 2015 menstrual disorder, polycystic ovary syndrome Tyumen State Medical Academy Unknown No outcome recorded
Phase 4 NCT01608698 Jun 2012 → Jan 2016 — Mahidol University Unknown Met primary
Phase not applicable10 trials · 2 missed
— NCT07127458 Aug 2025 → Mar 2026 polycystic ovary syndrome Ege University Completed No outcome recorded
— NCT06396221 May → Sep 2024 anovulation Chulalongkorn University Completed No outcome recorded
— NCT06345586 Apr 2024 → Jul 2026 overdue — Chulalongkorn University Recruiting No outcome recorded
— NCT04831151 Mar 2021 → Mar 2023 polycystic ovary syndrome Inonu University Unknown No outcome recorded
— NCT04984070 Jan 2021 → Dec 2023 mixed anxiety and depressive disorder, polycystic ovary syndrome Fudan University Unknown No outcome recorded
— NCT02865187 Feb 2017 → Mar 2020 polycystic ovary syndrome, sexual disorder Wright State University Completed Missed primary
— NCT02757469 May 2016 → May 2020 premature menopause Navy General Hospital, Beijing Unknown No outcome recorded
— NCT01459445 Feb → Jun 2011 polycystic ovary syndrome Iuliu Hatieganu University of Medicine and Pharmacy Unknown Mixed
— NCT00633360 Feb 2008 → May 2011 depressive disorder, premenstrual tension Massachusetts General Hospital Completed Missed primary
— NCT00442689 Jul 2006 → Nov 2012 metabolic syndrome X, polycystic ovary syndrome Northwestern University Completed No outcome recorded
Comparator or background therapy40 trials
Phase 1 NCT02874248 Comparator May → Nov 2016 — Estetra Completed No outcome recorded
Phase 1 NCT01291004 Comparator Jan 2011 → Mar 2012 — Teva Branded Pharmaceutical Products R&D, Inc. Completed No outcome recorded
Phase 1 NCT01258660 Background Dec 2006 → Jan 2008 — Bayer Completed No outcome recorded
Phase 2 NCT03091595 Comparator Feb 2017 → Jun 2018 — Estetra Completed No outcome recorded
Phase 2/3 NCT04256200 Comparator Feb 2017 → Nov 2021 endometriosis American University of Beirut Medical Center Unknown No outcome recorded

Evidence & citations 12 cited values

Every value below carries the sentence it was read from. 129 sources stand behind the page.

FieldValueCited text
Known as drospirenone “Participants received a monophasic combined oral contraceptive pills containing 0.03 mg ethinyl estradiol and 3 mg drospirenone (Technospiron® 0.03/3 mg, Technopharm, Egypt),...” NCT07229209 ↗
120

“15 mg estetrol and 3 mg drospirenone tablets administered once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day...” NCT02817841 ↗

“15 mg estetrol and 3 mg drospirenone tablets administered once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day...” NCT02817828 ↗

“Single-arm, Open-label, Interventional Study to Observe the Safety and Efficacy Profile of the Combined Oral Contraceptive YAZ®, a 24-day Cyclic Regimen Containing Drospirenone...” NCT02710708 ↗

“Combined oral contraceptive (COC; Yasmin; 0.03 mg ethinyl estradiol and 3 mg drospirenone); Subjects will start taking COC at / on the day of visit 2 and continue taking one...” NCT01254292 ↗

“OBJECTIVES: To investigate the long-term endometrial safety and bleeding pattern of the 0.25 mg drospirenone/0.5 mg 17β-estradiol (DRSP/E2) dose combination compared with 0.5...” PMID 23531117 ↗ May 2013

“The purpose of the study is to evaluate the effect of VX-407 on the pharmacokinetics of levonorgestrel (LNG) and ethinyl estradiol (EE), norgestimate (NGM) and EE,...” NCT07074327 ↗

“To evaluate the safety, compliance, and pharmacokinetics profile of estetrol monohydrate (E4) 15 mg combined with drospirenone (DRSP) 3 mg in post-menarchal participants...” NCT04792385 ↗

“Participants diagnosed with polycystic ovary syndrome (PCOS) during adolescence will receive a combined oral contraceptive (ethinylestradiol 30 µg + drospirenone 3 mg) once...” NCT07127458 ↗

“The objective of these study was to evaluate the effect of the use of a contraceptive containing 20 mcg of ethinyl estradiol and 3mg of drospirenone in the autonomic nervous...” NCT01590849 ↗

“Drospirenone and Ethinyl Estradiol Tablets, 3 mg DRSP and 30 mcg EE taken once daily from Day 1 of menstrual period up to and including Day 28 for 13 consecutive 28-day...” NCT00413062 ↗

Show 110 more sources

Known as BAY 86-4891 “E2/DRSP (BAY 86-4891) dose 1 (SH T04984E)” NCT00653614 ↗
Known as DROS “Continuous daily oral drospirenone (DROS; 3mg) + ethinyl estradiol (EE; 20ug)” NCT00927095 ↗
Known as drospirenone and ethinylestradiol tablets (I) “drospirenone and ethinylestradiol tablets (I) and (Ⅱ) will be used as an antiandrogen.” NCT04984070 ↗
Known as Drospirenone and Ethinylestradiol Tablets (Ⅱ) ClinicalTrials.gov intervention name — accepted as the source's own label NCT05872425 ↗
Known as DRSP “OBJECTIVE: To investigate the effects of an ethinylestradiol (EE) 20 μg/drospirenone (drsp) 3mg combined oral contraceptive (COC) administered in a 24/4 regimen (24 active...” PMID 21288628 ↗ Feb 2011
36

“LPRI-CF113 consists of 24 active white tablets containing drospirenone (DRSP) 4 mg followed by 4 active pink tablets containing DRSP 2.8 mg, taken orally once daily for 28...” NCT05461573 ↗

“A recent study in Japanese patients with dysmenorrhea (NCT01892904) reported a significant reduction in the number of days with menstrual pain after treatment with a flexible...” PMID 32210639 ↗ Mar 2020

“The objective of this study is to compare the red blood cell (RBC) and plasma concentrations of folate in subjects treated with drospirenone (DRSP)/ethinyl estradiol (EE) plus...” NCT01902264 ↗

“OBJECTIVES: To investigate the long-term endometrial safety and bleeding pattern of the 0.25 mg drospirenone/0.5 mg 17β-estradiol (DRSP/E2) dose combination compared with 0.5...” PMID 23531117 ↗ May 2013

“The purpose of the study is to evaluate the effect of VX-407 on the pharmacokinetics of levonorgestrel (LNG) and ethinyl estradiol (EE), norgestimate (NGM) and EE,...” NCT07074327 ↗

“To evaluate the safety, compliance, and pharmacokinetics profile of estetrol monohydrate (E4) 15 mg combined with drospirenone (DRSP) 3 mg in post-menarchal participants...” NCT04792385 ↗

“The purpose of the study is to assess the effects of BMS-986278 on Drospirenone (DRSP) and Ethinyl Estradiol (EE) when administered as a combined oral contraceptive in healthy...” NCT05985590 ↗

“Drospirenone and Ethinyl Estradiol Tablets, 3 mg DRSP and 30 mcg EE taken once daily from Day 1 of menstrual period up to and including Day 28 for 13 consecutive 28-day...” NCT00413062 ↗

“To evaluate long-term effects of drospirenone (DRSP)/ethinylestradiol (EE) alone, metformin alone and DRSP/EE plus metformin on some cardiovascular risk factors in...” NCT01581814 ↗

“1 pill daily-24 days of drospirenone 3 mg (3 mg DRSP)/ethinyl estradiol 20 μg (20 μg EE)/levomefolate calcium 0.451 mg (folate) -followed by 4 days of levomefolate calcium...” NCT01360996 ↗

Show 26 more sources

Known as E2/DRSP ClinicalTrials.gov intervention name — accepted as the source's own label NCT00653614 ↗
Known as LF111 “LF111 (drospirenone)” NCT02269241 ↗
Known as LF111 (drospirenone 4 mg tablet) “LF111 (drospirenone 4 mg tablet)” NCT05303636 ↗
Known as LF1111 “Drospirenone 4 mg tablet (LF1111)” NCT05303636 ↗
Action Inhibit “The antiandrogenic property of drospirenone means that it blocks the male sex hormones that can cause acne.” NCT00722800 ↗
Route Oral “given as tablets orally” NCT00102141 ↗