Drugs / ethinyl estradiol
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ethinyl estradiol

English name ethinylestradiol
also known as ethinyloestradiol · EE20 · EE · EE2

Small molecule

Developed for
polycystic ovary syndrome · dysmenorrhea · anovulation · acne · premenstrual dysphoric disorder · infertility disorder · menstrual disorder · premenstrual tension
+40 more · adenomyosis · depressive disorder · endometrial polyp · endometriosis · hemometra · major depressive disorder · migraine disorder · ovarian endometriosis · pelvis syndrome · premature menopause · primary dysmenorrhea · primary ovarian failure · systemic lupus erythematosus · uterine disorder · amenorrhea · anemia · anorexia nervosa · binge eating disorder · bone remodeling disease · breast cancer · chronic pain syndrome · COVID-19 · cystic fibrosis · endometrial cancer · functional hypothalamic amenorrhea · hidradenitis suppurativa · multiple sclerosis · osteoporosis · ovarian disorder · postpartum depression · pregnancy disorder · sexual disorder · temporomandibular joint disorder · endometrial disorder · female infertility · headache disorder · myocardial ischemia · ovarian cyst · ovarian dysfunction · uterine anomalies
Investigated by
Bayer · Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Pfizer · Boehringer Ingelheim · Novo Nordisk A/S
+179 more · AstraZeneca · Bristol-Myers Squibb · Nobelpharma · Wyeth is now a wholly owned subsidiary of Pfizer · Duramed Research · Eli Lilly and Company · Janssen Research & Development, LLC · GlaxoSmithKline · Population Council · Agile Therapeutics · Massachusetts General Hospital · AbbVie · Laboratorios Andromaco S.A. · Parexel · University of Colorado, Denver · Vertex Pharmaceuticals Incorporated · Warner Chilcott · Amgen · Bio-innova Co., Ltd · Canadian Institutes of Health Research (CIHR) · Celerion · Conselho Nacional de Desenvolvimento Científico e Tecnológico · FHI 360 · Janssen Pharmaceutica N.V., Belgium · Mahidol University · McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. · Novartis Pharmaceuticals · Oregon Health and Science University · Penn State University · Purdue University · Society of Family Planning · Teva Branded Pharmaceutical Products R&D, Inc. · Teva Women's Health · United States Agency for International Development (USAID) · University of Palermo · University of Pennsylvania · University of Roma La Sapienza · University of Saskatchewan · University of Virginia · ViiV Healthcare · Achillion, a wholly owned subsidiary of Alexion · Aegerion Pharmaceuticals, Inc. · Ain Shams Maternity Hospital · Alexion Pharmaceuticals, Inc. · Altimmune, Inc. · Anuja Dokras · Aquinox Pharmaceuticals (Canada) Inc. · Assembly Biosciences · Astellas Pharma Global Development, Inc. · Atea Pharmaceuticals, Inc. · Basilea Pharmaceutica International Ltd · Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma · Bial - Portela C S.A. · Biogen · Biolab Sanus Farmaceutica · Blueprint Medicines Corporation · Boston Children's Hospital · Bristol Myers Squibb Company (BMS) · CMN "20 de Noviembre" · CONRAD · Centers for Disease Control and Prevention · Chemo Research · Children's Mercy Hospital Kansas City · Chongqing Medical University · Chulalongkorn University · Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia · Concert Pharmaceuticals · Coordenação de Aperfeiçoamento de Pessoal de Nível Superior. · Covance · Deciphera Pharmaceuticals, LLC · Eastern Virginia Medical School · Ege University · Enanta Pharmaceuticals, Inc · Erasmus Medical Center · all 185 on the full record

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Evra — 2002-08-22 europa.eu ↗
Approved US (FDA) ESTINYL — 1943-06-25 fda.gov ↗

Trials 281 · started per year

today
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EU approved 2002
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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 05 trials
Phase 0 NCT07568509 May 2026 → Apr 2027 expected hypopituitarism, neurohypophyseal diabetes insipidus Massachusetts General Hospital Recruiting No outcome recorded
Phase 0 NCT03905941 Aug 2021 → Nov 2024 polycystic ovary syndrome University of Virginia Withdrawn No outcome recorded Stop: Business
Phase 0 NCT04423068 Dec 2020 → Apr 2022 pregnancy disorder Children's Mercy Hospital Kansas City Completed No outcome recorded
Phase 0 NCT03037944 Mar 2016 → Dec 2017 adenomyosis Ain Shams Maternity Hospital Unknown No outcome recorded
Phase 0 NCT02036879 Feb 2014 → Aug 2018 cystic fibrosis University of Texas Southwestern Medical Center Completed No outcome recorded
Phase 1122 trials · 4 met primary
Phase 1 NCT07808060 Sep 2026 → Jun 2027 expected obesity disorder Eli Lilly and Company Recruiting No outcome recorded
Phase 1 NCT07792408 Sep 2026 → Mar 2027 expected autosomal dominant polycystic kidney disease Vertex Pharmaceuticals Incorporated Recruiting No outcome recorded
Phase 1 NCT07710729 Jul 2026 → Apr 2027 expected obesity disorder Novo Nordisk A/S Not yet recruiting No outcome recorded
Phase 1 NCT07340190 Jun 2026 → Mar 2028 expected cancer Novartis Pharmaceuticals Recruiting No outcome recorded
Phase 1 NCT07539090 Jun → Oct 2026 expected — Deciphera Pharmaceuticals, LLC Recruiting No outcome recorded
Phase 1 NCT07523711 Apr → Nov 2026 expected obesity disorder Amgen Active not recruiting No outcome recorded
Phase 1 NCT07525791 Apr 2026 → May 2027 expected obesity disorder Novo Nordisk A/S Active not recruiting No outcome recorded
Phase 1 NCT07502417 Mar → Jul 2026 overdue — AbbVie Active not recruiting No outcome recorded
Phase 1 NCT07414784 Feb → Aug 2026 — AbbVie Completed No outcome recorded
Phase 1 NCT07388511 Feb → Apr 2026 — Blueprint Medicines Corporation Completed No outcome recorded
Show all 122 trials opens the full record — a long page
Phase 232 trials · 2 met primary · 2 missed
Phase 2 NCT07010146 Oct 2025 → Dec 2029 expected bone remodeling disease, functional hypothalamic amenorrhea University of Virginia Recruiting No outcome recorded
Phase 2 NCT07083635 Jul 2025 → Sep 2026 overdue hemometra, menstrual disorder Chulalongkorn University Recruiting No outcome recorded
Phase 2 NCT05098574 Feb 2023 → Apr 2024 bipolar disorder, premenstrual dysphoric disorder St. Joseph's Healthcare Hamilton Completed No outcome recorded
Phase 2 NCT05360550 Jul 2022 → Jan 2023 — Lupin Research Inc Completed 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 NCT02550977 Sep 2015 → Jul 2016 — Bayer Completed No outcome recorded
Phase 2 NCT01968135 Oct 2013 → Nov 2014 uterine disorder University of Colorado, Denver Completed Met primary
Phase 2 NCT01388491 Oct 2011 → Sep 2012 vascular hemostatic disease Teva Branded Pharmaceutical Products R&D, Inc. Completed Met primary
Phase 2 NCT01310647 Jun 2011 → Dec 2012 ovarian disorder La Fe Health Research Institute Completed Missed primary
Phase 2 NCT01252186 Nov 2010 → Dec 2011 vascular hemostatic disease Teva Women's Health Completed No outcome recorded
Phase 2/34 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 2/3 NCT00955058 Feb 2007 polycystic ovary syndrome Shahid Beheshti University Unknown No outcome recorded
Phase 2/3 NCT00310791 Apr 2004 → Oct 2009 anorexia nervosa Boston Children's Hospital Completed No outcome recorded
Phase 358 trials · 9 met primary · 1 missed
Phase 3 NCT07714616 May 2027 → May 2029 expected — Eurofarma Laboratorios S.A. Not yet recruiting No outcome recorded
Phase 3 NCT05139121 Oct 2021 → Jan 2025 — Viatris Inc. Completed No outcome recorded
Phase 3 NCT03945513 Dec 2019 → Jun 2023 — Insud Pharma Completed No outcome recorded
Phase 3 NCT04007874 Sep 2019 → Dec 2024 migraine disorder Leiden University Medical Center Unknown No outcome recorded
Phase 3 NCT03843736 Feb 2019 → Jun 2020 polycystic ovary syndrome Peking Union Medical College Hospital Unknown No outcome recorded
Phase 3 NCT03229057 Jan 2018 → Jan 2024 polycystic ovary syndrome Anuja Dokras Completed Missed primary
Phase 3 NCT02922348 Mar 2016 → Dec 2018 primary ovarian failure University of Pennsylvania Withdrawn No outcome recorded
Phase 3 NCT02617537 Jan 2016 → Sep 2017 dysmenorrhea Bayer Withdrawn No outcome recorded
Phase 3 NCT02362711 Feb 2015 → Jan 2017 dysmenorrhea Nobelpharma Completed No outcome recorded
Phase 3 NCT02158572 Aug 2014 → Nov 2016 — Agile Therapeutics Completed No outcome recorded
Phase 433 trials · 2 met primary · 1 missed
Phase 4 NCT06334315 Oct 2024 → May 2028 expected — Yale University Recruiting No outcome recorded
Phase 4 NCT06067256 Jul → Dec 2023 — Italfarmaco Unknown No outcome recorded
Phase 4 NCT06324851 Jan → Aug 2023 endometrial polyp University of Palermo Completed No outcome recorded
Phase 4 NCT06316206 Jan → Aug 2023 endometrial polyp University of Palermo Completed No outcome recorded
Phase 4 NCT05002738 Sep 2021 → Nov 2022 — University of Colorado, Denver Completed No outcome recorded
Phase 4 NCT04828824 Jun 2021 → Nov 2025 — University of Colorado, Denver Completed No outcome recorded
Phase 4 NCT03077555 Jan 2017 → Feb 2018 anovulation Mahidol University Completed No outcome recorded
Phase 4 NCT02710708 May 2016 → Jul 2018 — Bayer Completed No outcome recorded
Phase 4 NCT02531321 Aug 2015 → Nov 2016 HIV infectious disease University of Southern California Terminated No outcome recorded Stop: Enrollment
Phase 4 NCT02352090 Apr 2015 → Dec 2018 — Helsinki University Central Hospital Completed Missed primary
Phase not applicable27 trials · 3 missed
— NCT07361263 Jan 2026 → Feb 2027 expected diabetes insipidus University Hospital, Basel, Switzerland Recruiting No outcome recorded
— NCT07127458 Aug 2025 → Mar 2026 polycystic ovary syndrome Ege University Completed No outcome recorded
— NCT05233956 Oct 2023 → Dec 2026 expected anemia FHI 360 Active not recruiting No outcome recorded
— NCT04778514 Dec 2022 → Sep 2023 HIV infectious disease Population Council Completed No outcome recorded
— NCT05212389 Dec 2021 → Aug 2024 disease by molecular mechanism, major depressive disorder Rigshospitalet, Denmark Unknown No outcome recorded
— NCT02556411 Jun → Dec 2021 adenomyosis, chronic pain syndrome University of Cagliari Unknown No outcome recorded
— NCT04831151 Mar 2021 → Mar 2023 polycystic ovary syndrome Inonu University Unknown No outcome recorded
— NCT04539626 Oct 2020 → Apr 2023 COVID-19 CMN "20 de Noviembre" Unknown No outcome recorded
— NCT04451746 Jun 2020 → Feb 2026 chronic venous insufficiency Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia Completed No outcome recorded
— NCT06560944 Jan 2020 → Jan 2024 — University of Lincoln Completed No outcome recorded
Comparator or background therapy108 trials
Phase 0 NCT02689843 Comparator Feb → Nov 2018 polycystic ovary syndrome Shiraz University of Medical Sciences Completed No outcome recorded
Phase 1 NCT07269327 Background Nov 2025 → Mar 2026 infertility disorder Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany Completed No outcome recorded
Phase 1 NCT05282940 Comparator Feb → Mar 2022 — Laboratorios Andromaco S.A. Completed No outcome recorded
Phase 1 NCT04713904 Comparator Jan 2021 — Laboratorios Andromaco S.A. Completed No outcome recorded
Phase 1 NCT04272008 Comparator Mar 2020 → Jun 2021 — TherapeuticsMD Completed No outcome recorded
Show all 108 trials opens the full record — a long page

News releases announcing trial results or a regulatory action · 25

DateIssuerRelease
2026-07-29 Pfizer's Upjohn has merged with Mylan to form Viatris Inc. Regulatory Viatris Receives U.S. FDA Approval for Gwyn Lo™, a Once-Weekly Contraceptive Patch viatris.com ↗
Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced that the U.S. Food and Drug Administration (FDA) has approved Gwyn Lo™ (norelgestromin and ethinyl estradiol transdermal system).
2026-02-12 Teva Canada Regulatory Important: Voluntary Nationwide Recall PrSEASONIQUE Oral Contraceptive tevacanada.com ↗
Important: Voluntary Nationwide Recall PrSEASONIQUE Oral Contraceptive
2026-02-12 Teva Canada Regulatory Important: Voluntary Nationwide Recall PrSEASONALE Extended‑Cycle Oral Contraceptive Tablets tevacanada.com ↗
Teva Canada Limited, with the knowledge of Health Canada, is initiating a nationwide voluntary Type I recall at the patient (consumer) level of one lot of PrSEASONALE (DIN 02296659) 3×91 Extended‑Cycle Oral Contraceptive Tablets.
2025-12-18 Pfizer's Upjohn has merged with Mylan to form Viatris Inc. Regulatory Viatris Provides Pipeline Update on Four Regulatory Milestones viatris.com ↗
The U.S. FDA has accepted for review the New Drug Application (NDA) for the Company's investigational low dose estrogen weekly patch (150 mcg norelgestromin and 17.5 mcg ethinyl estradiol) for contraception.
2025-06-04 Teva Canada Regulatory Important Information - Voluntary Nationwide Recall SEASONIQUE tevacanada.com ↗
Toronto, Canada (June 4, 2025) - Teva Canada Limited, with the knowledge of Health Canada, is initiating a nationwide voluntary Type I to the Patient (Consumer) level recall of one (1) lot of prescription drug SEASONIQUE Oral Contraceptive 2x91 Extended-Cycle Tablet Dispenser
2025-05-08 Pfizer's Upjohn has merged with Mylan to form Viatris Inc. Results Viatris Announces Positive Results from Phase 3 Study of Investigational XULANE LO™ Low Dose Patch for Birth Control in Women of Childbearing Potential viatris.com ↗
In this study, XULANE LO demonstrated a favorable efficacy and safety profile with no new safety concerns identified as well as a potential best-in-class patch performance profile.
2025-05-02 Teva Canada Regulatory Important Information - Voluntary Nationwide Recall PrSEASONIQUE® tevacanada.com ↗
Teva Canada Limited, with the knowledge of Health Canada, is initiating a nationwide voluntary Type I to the Patient (Consumer) level recall of one (1) lot of prescription drug PrSEASONIQUE® Oral Contraception Tablets 2x91 Extended-Cycle Tablet Dispenser due to the possibility of missing tablets.
2024-02-16 Lupin Limited Regulatory Lupin Receives Approval from U.S. FDA for Minzoya (Levonorgestrel and Ethinyl Estradiol Tablets, USP and Ferrous Bisglycinate Tablets) lupin.com ↗
2023-08-01 Lupin Limited Regulatory Lupin Receives Approval from US FDA for Turqoz® (Norgestrel and Ethinyl Estradiol Tablets USP) lupin.com ↗
Mumbai, Baltimore, August 01, 2023: Global pharma major Lupin Limited (Lupin) today announced that it has received approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application for Turqoz® (Norgestrel and Ethinyl Estradiol Tablets USP)0.3 mg/0.03 mg, to market a generic equivalent of Lo/Ovral-28 (Norgestrel and Ethinyl Estradiol Tablets)0.3 mg/0.03 mg of Wyeth Pharmaceuticals LLC.
2021-07-17 ViiV Healthcare Results ViiV Healthcare to present new data from diverse portfolio and pipeline of 2-drug and long-acting regimens for HIV treatment and prevention at IAS 2021 viivhealthcare.com ↗
Injection site reactions were more frequent in the CAB-LA arm.
2021-07-12 Merck Sharp & Dohme LLC Results Merck Announces Presentation of New Data from Broad HIV Program at IAS 2021 merck.com ↗
NNRTI MK-8507 Does Not Alter the Pharmacokinetics of the Combined Oral Contraceptive Levonorgestrel/Ethinyl Estradiol.
2019-07-09 AbbVie Results Allergan Continues to Demonstrate Leadership in Migraine with 29 Presentations at the 2019 American Headache Society Annual Meeting abbvie.com ↗
Absence of Clinically Significant Drug Interactions With Coadministration of Atogepant and an Ethinyl Estradiol/Levonorgestrel Oral Contraceptive in Healthy Female Subjects: A Phase 1 Pharmacokinetic Analysis.

All press releases naming this drug 32 releases

DateIssuerRelease

Evidence & citations 8 cited values

Every value below carries the sentence it was read from. 400 sources stand behind the page.

FieldValueCited text
Known as ethinylestradiol “The proposed study will use participants that currently use a specific preparation of oral contraceptive (30micrograms ethinyl estradiol and 150mg Levonorgestrel) and compare...” NCT06560944 ↗
397

“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 ↗

“OCP containing 35 microgram ethinylestradiol and 2-milligram cyproterone acetate to taken from the first day of the menstruation, oral administration of one pill daily for 21...” NCT03236740 ↗

“combined oral contraceptive pill (OCP) once daily for 21 days (Desogestrel 150 micrograms/ Ethinylestradiol 30 micrograms, tablets), starting from the first day of menses, then...” NCT05594186 ↗

“The purpose of the proposed project is to address the potential mechanism(s) by which oral ethinyl estradiol (EE) may negatively impair bone via "first pass" effects on the...” NCT02367833 ↗

“The aim of this study was to investigate the bleeding pattern and cycle control of a contraceptive patch containing 0.55 mg ethinyl estradiol (EE) and 2.1 mg gestodene (GSD)...” PMID 25453585 ↗ Oct 2014

“A study to assess the Pharmacokinetics (PK) of combined oral ethinyl estradiol (EE) and levonorgestrel (LNG) in healthy female participants of non-child-bearing potential, when...” NCT05505162 ↗

“An Open-Label, Single-Sequence, Crossover Study to Investigate the Interaction of Multiple Doses of BMS-986322 at Steady State and Multiple Doses of a Combined Oral Hormonal...” NCT05579574 ↗

“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 ↗

“Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10...” NCT01252186 ↗

“OBJECTIVE(S): To investigate the bleeding pattern and cycle control parameters of a contraceptive patch containing 0.55 mg ethinyl estradiol (EE) and 2.1 mg gestodene (GSD)...” PMID 25453582 ↗ Oct 2014

Show 387 more sources

Known as EE ClinicalTrials.gov intervention name — accepted as the source's own label NCT03091595 ↗
Known as EE2 “STUDY DESIGN: Thirty-three women were randomly assigned 1:1 to one of two OCs with 35-mcg ethinylestradiol (EE2) but different doses of NET - 1 or 0.4 mg.” PMID 22325110 ↗ Feb 2012
Known as EE20 “20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP)” NCT00266032 ↗
1

“Ethinyl Estradiol 20 (EE20)/DRSP (YAZ, BAY86-5300)” NCT02710708 ↗

Known as ethinyloestradiol “The volunteers received an oral single-dose of a combined contraceptive containing 30 μg ethinyloestradiol and 150 μg levonorgestrel on two occasions - once as such and once...” NCT02281448 ↗
5

“An Open-label, Fixed-sequence and Two-part Study to Assess the Impact of Multiple Doses of Itraconazole on the Pharmacokinetics of AZD5004 in Healthy Participants and Multiple...” NCT06942936 ↗

“with a monophasic COC containing ethinyloestradiol/levonorgestrel (EE/LNG), with regard to their ability to reduce the frequency and intensity of headache and pelvic pain” PMID 23919857 ↗ Aug 2013

“7 days daily intake of oral capsule containing containing ethinyl oestradiol 30micrograms plus desogestrel 150 micrograms followed by 14 days oral placebo capsules” NCT01384331 ↗

“ethinyl oestradiol 20ug plus gestodene 75ug during 6 cycles” NCT01372293 ↗

NCT01137708 ↗

Action Inhibit “Inhibition of Ovulation” NCT00915915 ↗
Modality Small molecule “14-day course of combined oral hormonal steroids” NCT01968135 ↗
Route Oral “oral contraceptives (triphasic ethinyl estradiol at a dose of 35 microg” PMID 16354891 ↗ Dec 2005