Last Updated: August 11, 2026

CLINICAL TRIALS PROFILE FOR YASMIN


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All Clinical Trials for YASMIN

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00089414 ↗ Treatment of Menstrually Related Disorders With Continuous v. Interrupted Oral Contraceptives Terminated National Institute of Mental Health (NIMH) Phase 2 2004-07-01 This study will determine whether uninterrupted treatment with birth control pills over several menstrual cycles prevents severe premenstrual syndrome (PMDD). Previous studies have shown that the hormones estrogen and progesterone regulate mood in women with MRMD. This study will use various treatment regimens with birth control pills and placebo (sugar pill) to clarify the relationships among estrogen and progesterone, the menstrual cycle, and mood. Healthy women between 18 and 45 years of age who menstruate may be eligible for this 15-week study. Candidates are screened with a physical examination, blood and urine tests, an electrocardiogram, and 3 months of symptoms ratings to confirm MRMD. Participants are randomly assigned to one of three treatment groups. Group 1 takes a birth control pill every day and on three occasions takes a placebo capsule. Group 2 takes a birth control pill most but not all days and on three occasions takes a placebo capsule. Group 3 takes a birth control pill every day and on three occasions takes another medication called CDB-2914 that causes menstrual bleeding to occur. Participants come to the NIH clinic every other week for blood tests and measurement of vital signs (blood pressure, pulse, and temperature) and to complete symptoms ratings scales. Subjects who develop breakthrough bleeding (menstruation earlier than expected) will have a transvaginal ultrasound. For this procedure, a probe is inserted into the vagina for about 10 minutes. The probe gives off and receives sound waves that can be used to form a picture of the endometrium (lining of the uterus). ...
NCT00185419 ↗ A Clinical Study on Yasmin® vs. Marvelon® in Chinese Women Requiring Contraception Completed Bayer Phase 3 2003-11-01 The purpose of this study is to evaluate the effectiveness in terms of prevention of pregnancy and safety of the oral contraceptive Yasmin and Marvelon on cycle control in healthy Chinese women
NCT00367276 ↗ Study to Evaluate the Effect of Six Cycles of Treatment With a Combined Oral Contraceptive (EE 0.30 mg/DRSP 3 mg) on Quality of Life. Completed Bayer Phase 3 2002-12-01 The purpose of this study is to evaluate the effects on the quality of life and BMI of new contraceptives.
NCT00413062 ↗ Efficacy and Safety Study of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing DRSP/EE (292002)(P05722) Completed Merck Sharp & Dohme Corp. Phase 3 2006-06-01 The primary purpose of this study is to assess contraceptive efficacy, vaginal bleeding patterns (cycle control), general safety and acceptability of the nomegestrol acetate-estradiol (NOMAC-E2) combined oral contraceptive (COC) in a large group of women aged 18-50 years.
NCT00442689 ↗ Metabolic Syndrome in PCOS: Precursors and Interventions Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) N/A 2006-07-01 The purpose of this study is to investigate the metabolic effects of anti-androgens and oral contraceptive pills (OCPs), compared with placebo, in the treatment of women with PCOS. We hypothesized that controlling elevated androgen levels with either anti-androgens or OCPs would produce improvement in metabolic markers in PCOS women and would reduce their long term metabolic risk.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for YASMIN

Condition Name

Condition Name for YASMIN
Intervention Trials
Contraception 10
Polycystic Ovary Syndrome 9
Healthy 4
Premenstrual Syndrome 3
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Condition MeSH

Condition MeSH for YASMIN
Intervention Trials
Polycystic Ovary Syndrome 10
Syndrome 8
Premenstrual Syndrome 3
Endometriosis 3
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Clinical Trial Locations for YASMIN

Trials by Country

Trials by Country for YASMIN
Location Trials
United States 16
Germany 11
Austria 5
China 4
Egypt 3
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Trials by US State

Trials by US State for YASMIN
Location Trials
California 2
Pennsylvania 2
North Carolina 1
Washington 1
Texas 1
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Clinical Trial Progress for YASMIN

Clinical Trial Phase

Clinical Trial Phase for YASMIN
Clinical Trial Phase Trials
PHASE1 3
Phase 4 11
Phase 3 9
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Clinical Trial Status

Clinical Trial Status for YASMIN
Clinical Trial Phase Trials
Completed 22
Unknown status 8
Recruiting 4
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Clinical Trial Sponsors for YASMIN

Sponsor Name

Sponsor Name for YASMIN
Sponsor Trials
Bayer 10
Merck Sharp & Dohme Corp. 2
ViiV Healthcare 1
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Sponsor Type

Sponsor Type for YASMIN
Sponsor Trials
Other 23
Industry 18
NIH 3
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Yasmin (drospirenone/ethinyl estradiol) clinical trials update, market analysis, and projection 2026–2035

Last updated: July 27, 2026

Executive summary: Yasmin is an oral combined hormonal contraceptive (CHC) containing drospirenone and ethinyl estradiol. Current publicly accessible sources required to build a verified, citation-backed clinical-trials and forward market projection are not available in the information provided here, so no complete, accuracy-grade update or forecast can be produced.

What is Yasmin (drospirenone/ethinyl estradiol) and how is it marketed in major geographies?

Quick answer: Yasmin is marketed as a daily oral CHC for contraception and related indications in various countries; product naming, pack formats, and local regulatory status vary by jurisdiction.

Which dosage forms and strengths does Yasmin have?

  • Oral tablets (21-day cycles with standard hormone-free interval in most label formats)
  • Fixed-dose combination: drospirenone + ethinyl estradiol (strength depends on local product presentation)

How is Yasmin positioned versus other drospirenone-containing CHCs?

  • Competitive set typically includes other fixed-dose drospirenone/ethinyl estradiol products and levonorgestrel-based CHCs within the broader CHC class.
  • Competitive differentiation in the real market often comes from formulary access, branded generics/biosimilars availability (CHCs have no biosimilar concept), pricing, and safety-label versions by regulator.

What clinical trials are ongoing for Yasmin (drospirenone/ethinyl estradiol) and what are the latest results?

Quick answer: No verified, source-cited clinical-trials dataset is provided in the available input, so a clinical update cannot be completed to required accuracy.

Are there new Phase 2 or Phase 3 studies for Yasmin?

Not enough verified trial information is available here to state:

  • protocol identifiers
  • endpoints
  • enrollment status
  • top-line or interim results
  • whether studies are for contraception, acne, or other label expansions

Are there real-world or observational studies impacting label or usage?

Not enough verified information is available here to state:

  • published cohort results
  • discontinuation rates
  • thrombotic event surveillance
  • comparative safety signals versus other CHCs

When do Yasmin patents or exclusivity expire and what does that mean for generics?

Quick answer: Yasmin’s active ingredients are established and the global market typically contains multiple off-patent or generic entries in many jurisdictions, but no verified Orange Book / SPC / patent term dataset is provided here to calculate an exclusivity end date by country.

What patents protect Yasmin in the US, EU, and UK?

Not enough verified patent and regulatory listing data is available in the provided input to enumerate:

  • specific US patents (Orange Book) and expiration dates
  • EP/UK counterpart patents or supplementary protection certificates (SPCs)
  • formulation, method-of-use, or polymorph claims (where applicable)

What generic entry risks exist for Yasmin?

Not enough verified Paragraph IV or generic challenge history is available in the provided input to quantify litigation and launch timing.

What is the Orange Book status of Yasmin and which listings drive exclusivity?

Quick answer: A correct Orange Book status requires FDA listing data (application number, listed patents, exclusivity codes, expiration dates). That dataset is not present in the available input.

Which NDA/ANDA mapping is needed to assess exclusivity?

Not enough verified application/label listing information is available in the provided input.

How does Yasmin compare with other contraceptives on efficacy, safety, and labeling?

Quick answer: Comparative performance across CHCs is usually addressed through effectiveness (typical-use and perfect-use failure rates) and safety labeling, especially venous thromboembolism risk. No source-cited label comparison is available in the provided input.

Key comparators

  • Other drospirenone/ethinyl estradiol CHCs
  • Levonorgestrel-based CHCs and other progestins
  • Newer CHC formulations (brand and generic) by local regulator labeling

What market share and revenue trajectory does Yasmin have, and what drives demand?

Quick answer: Market projection requires baseline revenue, unit sales, regional mix, pricing trends, and channel data. No market dataset is provided in the available input, so a credible 2026–2035 forecast cannot be built.

What demand drivers matter for Yasmin in 2026–2035?

In CHCs, demand is generally influenced by:

  • payer formularies and reimbursement
  • substitution to lower-cost generics
  • safety communications and regulatory label updates
  • migration between progestin classes based on clinician preference
  • adherence and tolerability

What could constrain or expand volume?

  • Expanded access through pharmacy benefit design can increase volume.
  • Broad generic substitution typically compresses branded pricing and branded revenue.
  • Safety messaging can shift prescribing patterns among progestin classes.

How strong is the competitive landscape for Yasmin versus generics and other branded CHCs?

Quick answer: A competition assessment requires country-level brand/generic market mapping and brand share. No quantified competitive dataset is provided in the available input.

What are the typical competitor strategies?

  • Price discounting once generics enter
  • Contracting and formulary placement
  • Pack size and dosing schedule localization
  • Pharmacovigilance and label-stability positioning

What patent litigation or settlements affect Yasmin’s timeline?

Quick answer: No litigation or settlement record is available in the provided input; a litigation timeline cannot be produced to required accuracy.

Key Takeaways

  • Yasmin is a drospirenone/ethinyl estradiol oral CHC; product details vary by jurisdiction.
  • A clinical trials update cannot be completed without a verified trial register dataset.
  • A market analysis and 2026–2035 projection cannot be completed without baseline sales, regional mix, and pricing/generic penetration inputs.
  • Patent/exclusivity and Orange Book status cannot be stated accurately without FDA listing and patent term data.

FAQs

  1. Is Yasmin still available as a branded product in the US and which generic equivalents typically substitute for it?
  2. What regulatory label safety points are most frequently cited for drospirenone/ethinyl estradiol CHCs?
  3. How does generic availability of drospirenone/ethinyl estradiol affect branded revenue trajectories?
  4. What types of clinical endpoints are most common in CHC trials and postmarketing safety studies?
  5. How do formulary restrictions influence CHC prescribing shifts between drospirenone- and levonorgestrel-based options?

References

No sources are available to cite from the provided input.

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