CLINICAL TRIALS PROFILE FOR YASMIN

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.

Clinical Trial Conditions for YASMIN

Condition Name

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

Condition MeSH

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

Clinical Trial Locations for YASMIN

Trials by Country

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

Trials by US State

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

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

Clinical Trial Status

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

Clinical Trial Sponsors for YASMIN

Sponsor Name

Sponsor Name for YASMIN
Sponsor	Trials
Bayer	10
Merck Sharp & Dohme Corp.	2
University of California, San Francisco	1

Sponsor Type

Sponsor Type for YASMIN
Sponsor	Trials
Other	23
Industry	18
NIH	3

Clinical Trials Update, Market Analysis, and Projection for YASMIN

Last updated: October 29, 2025

Introduction

YASMIN, a combined oral contraceptive (COC), has maintained its prominence within the global reproductive health market. Launched primarily as a contraceptive solution, YASMIN's formulation leverages a unique combination of drospirenone and ethinylestradiol, offering an alternative to traditional contraceptives with benefits such as reduced water retention and lower androgenic activity. This analysis explores the latest updates on clinical trials, reviews current market dynamics, and projects future growth trajectories for YASMIN within the competitive pharmaceutical landscape.

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Clinical Trials Update

Ongoing and Recent Clinical Investigations

YASMIN's pharmacovigilance and efficacy reviews continue to underpin its regulatory status. The most recent clinical activities have focused on expanding indications, particularly exploring non-contraceptive benefits such as acne treatment, premenstrual dysphoric disorder (PMDD), and reduction of ovarian cyst formation.

While YASMIN's flagship clinical trials were completed years prior, recent investigations have centered on its long-term safety profile. These retrospective, observational studies reinforce existing data indicating a low incidence of adverse effects such as venous thromboembolism (VTE), a common concern with drospirenone-based contraceptives [1].

Pharmacovigilance and Post-Market Surveillance

Regulatory agencies like the FDA and EMA have maintained rigorous post-market surveillance, with no significant safety signals reported over the past two years. Nonetheless, ongoing pharmacovigilance efforts continue, adapting to the updated guidelines on hormone therapy safety protocols. These efforts are particularly vital given awareness around VTE risk, which has impacted regulatory labels and prescribing practices globally.

Research on Non-Contraceptive Uses

Emerging research indicates potential off-label applications of drospirenone-containing pills, including YASMIN, in managing symptoms associated with hormonal imbalance. Clinical trials assessing these indications are still in preliminary phases, with no conclusive data yet prompting formal regulatory approval.

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Market Analysis

Global Market Position

YASMIN remains a leading product within the combined oral contraceptive market, valued at approximately USD 4.8 billion in 2022, with a compound annual growth rate (CAGR) projected around 4.2% from 2023 to 2028 [2]. Its market dominance is primarily due to its unique formulation, favorable side effect profile, and extensive clinical backing.

Key Market Segments

• Geographic Distribution: North America and Europe constitute the largest markets, owing to high contraceptive awareness and regulatory approvals. Emerging markets such as Asia-Pacific are witnessing rapid growth driven by increasing urbanization, changing gender norms, and evolving family planning policies.

• Demographic Trends: Women aged 18-34 form the core consumer base, with an expanding segment of women seeking long-term hormonal contraceptive options with minimal side effects.

• Competitive Landscape: Major competitors include Yasmin’s branded formulations and other drospirenone-based contraceptives like Yasminelle and Slynd, as well as generics. Innovative delivery systems, such as extended-cycle pills and non-hormonal options, pose competitive challenges.

Regulatory and Reimbursement Factors

Recent regulatory updates have emphasized safety monitoring, especially concerning VTE risks associated with drospirenone. While some countries have imposed boxed warnings, reimbursement policies remain favorable in many developed markets, facilitating accessible pricing models.

Market Challenges

Key hurdles include growing public and regulatory scrutiny over hormonal contraceptives' safety, patent expirations leading to increased generic competition, and societal shifts favoring non-hormonal methods.

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Market Projection

Growth Drivers

• Expanding Global Markets: Increased contraceptive use in Asia-Pacific and Latin America, driven by public health initiatives.

• Product Extensions: Development of extended-cycle formulations and combination therapies aimed at reducing pill burden.

• Non-Contraceptive Indications: Growing evidence for additional uses such as acne and hormonal regulation, potential to diversify revenue streams.

Forecast Modeling

Based on current market data and anticipated regulatory adaptations:

• The global market for drospirenone-based contraceptives, including YASMIN, is expected to reach USD 6.4 billion by 2028.
• YASMIN's market share may decline marginally in the face of generic competition but will sustain demand due to brand loyalty and clinical trust.

Strategic Outlook

Pharmaceutical companies investing in robust pharmacovigilance and marketing strategies to communicate the safety profile could reinforce YASMIN’s position. Additionally, collaborations with health authorities for expanded indications may open new revenue channels.

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Key Takeaways

• Clinical Stability: Clinical data and post-market surveillance affirm YASMIN's safety profile, particularly regarding VTE risks, maintaining regulatory and consumer trust.

• Market Dynamics: The contraceptive market remains robust, with growth driven by emerging markets and demographic shifts, ensuring sustained demand for drospirenone-based pills.

• Competitive Landscape: While patent expirations and generics threaten market share, YASMIN’s established clinical reputation and brand recognition serve as key differentiators.

• Future Opportunities: Expanding indications and developing innovative formulations could enable YASMIN to retain and grow its market share amid evolving regulatory and societal trends.

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FAQs

Q1: What are the primary safety concerns associated with YASMIN?
A: The primary safety concern is the increased risk of venous thromboembolism (VTE), especially in women with additional risk factors. Regulatory agencies have emphasized ongoing monitoring, but current evidence indicates that, with appropriate screening, YASMIN maintains a manageable safety profile.

Q2: How does YASMIN compare with generic drospirenone-based contraceptives?
A: YASMIN benefits from longstanding clinical data, brand recognition, and high consumer trust. Generics often offer cost advantages but may lack the comprehensive clinical backing that supports YASMIN’s premium positioning.

Q3: Are there new clinical trials planned for YASMIN?
A: Currently, most ongoing research pertains to pharmacovigilance and post-market safety. Investigation into expanded therapeutic indications remains preliminary, with no extensive new trials publicly announced.

Q4: What are the key factors influencing YASMIN’s market projection?
A: Factors include demographic trends, regulatory environment, market competition, safety perceptions, and the development of alternative contraceptive methods.

Q5: Can YASMIN be used for non-contraceptive indications?
A: While research is ongoing, YASMIN is primarily approved as a contraceptive. Its off-label use for conditions like acne or hormonal issues remains experimental and is not officially recommended without regulatory approval.

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References

[1] Shulman, L., et al. (2021). Post-Marketing Surveillance of Drospirenone-Containing Contraceptives. Journal of Women's Health.

[2] Market Research Future. (2022). Global Contraceptive Market Analysis and Forecast.