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	3
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	10
Austria	5
Egypt	3
Italy	3

Trials by US State

Trials by US State for Yasmin
Location	Trials
Pennsylvania	2
California	2
North Dakota	1
Illinois	1
Maryland	1

Clinical Trial Progress for Yasmin

Clinical Trial Phase

Clinical Trial Phase for Yasmin
Clinical Trial Phase	Trials
Phase 4	11
Phase 3	9
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Yasmin
Clinical Trial Phase	Trials
Completed	21
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
GlaxoSmithKline	1

Sponsor Type

Sponsor Type for Yasmin
Sponsor	Trials
Other	23
Industry	15
NIH	3

Yasmin: Clinical Trials, Market Analysis, and Projections

Introduction

Yasmin, a combined hormonal oral contraceptive (COC) containing drospirenone (DRSP) and ethinyl estradiol (EE), has been a subject of extensive clinical trials, market analysis, and safety evaluations. Here, we delve into the current state of Yasmin, including its clinical trials, market dynamics, and future projections.

Clinical Trials and Safety Evaluations

Approval and Initial Studies

Yasmin was approved by the FDA in 2006 for use as an oral contraceptive. It was also approved for the treatment of moderate acne vulgaris and premenstrual dysphoric disorder (PMDD) in women who choose to use an oral contraceptive[2].

Venous Thromboembolism (VTE) Risk

One of the primary concerns with Yasmin is its association with an increased risk of venous thromboembolism (VTE). Several studies have compared the VTE risk of Yasmin users to those using other COCs. The EURAS and Ingenix studies found that the risk of thromboembolism in Yasmin users was comparable to that of other COCs, including those containing levonorgestrel[1][4].

However, other studies, such as the van Hylckama Vlieg et al. and Lidegaard et al. studies, suggested a higher risk of VTE in Yasmin users compared to users of levonorgestrel-containing COCs, although these findings were not universally consistent and had limitations[1][5].

Litigation and Regulatory Scrutiny

The safety concerns surrounding Yasmin have led to significant litigation. The multidistrict litigation (MDL) involving Yasmin and its sister drug, YAZ, has focused on whether Bayer misrepresented or omitted facts about the safety and efficacy of these drugs, particularly regarding the increased risk of VTE and other thrombotic events[2].

Market Analysis

Market Position

Yasmin, along with other DRSP-containing COCs like YAZ and Beyaz, occupies a niche in the oral contraceptive market. These drugs are often marketed for their additional benefits, such as acne treatment and PMDD management, which can attract a specific segment of users[2].

Competition and Alternatives

The oral contraceptive market is highly competitive, with various types of COCs available. Yasmin competes with other COCs containing different progestins, such as levonorgestrel and desogestrel. The choice of contraceptive often depends on individual health profiles and risk factors, with healthcare providers considering the potential risks and benefits of each option[5].

Pricing and Advertising

Newer COCs like Yasmin, which contain drospirenone, tend to be more expensive and are often heavily advertised. This can create a perception that these newer drugs are more effective or safer, even though the FDA does not require new drugs to be an improvement over older ones. This marketing strategy can influence consumer and prescriber preferences[5].

Projections and Future Outlook

Regulatory Environment

Given the ongoing regulatory scrutiny and litigation, the future of Yasmin and other DRSP-containing COCs depends on how these safety concerns are addressed. The FDA continues to monitor and update labeling to reflect the latest safety data, which can impact prescribing practices and consumer confidence[4][5].

Prescriber and Consumer Awareness

Healthcare professionals are increasingly aware of the potential risks associated with Yasmin and are advised to discuss these risks with patients. This heightened awareness could lead to more cautious prescribing and a shift towards other COCs with perceived lower risk profiles[5].

Market Trends

The oral contraceptive market is evolving, with a focus on safety, efficacy, and additional benefits. As more data becomes available and regulatory guidelines are updated, the market share of Yasmin and similar drugs may fluctuate. Consumers and prescribers are likely to seek out options that balance effectiveness with minimal risk[5].

Key Takeaways

• Safety Concerns: Yasmin is associated with an increased risk of VTE compared to some other COCs, although findings vary across studies.
• Regulatory Scrutiny: Ongoing litigation and FDA monitoring highlight the need for careful risk-benefit analysis.
• Market Dynamics: Yasmin competes in a crowded market with other COCs, and its market position may be influenced by safety concerns and regulatory updates.
• Consumer Awareness: Increased awareness among healthcare providers and consumers about the potential risks of Yasmin could impact its usage.

FAQs

Q: What are the primary components of Yasmin?

A: Yasmin contains 3 mg of drospirenone (DRSP) and 0.03 mg of ethinyl estradiol (EE)[1][4].

Q: What are the approved uses of Yasmin?

A: Yasmin is approved for pregnancy prevention, moderate acne vulgaris, and premenstrual dysphoric disorder (PMDD) in women who choose to use an oral contraceptive[2].

Q: Is Yasmin associated with an increased risk of blood clots?

A: Yes, several studies suggest that Yasmin may be associated with a higher risk of venous thromboembolism (VTE) compared to some other COCs[1][4][5].

Q: What are the contraindications for Yasmin?

A: Contraindications include renal impairment, adrenal insufficiency, high risk of arterial or venous thrombotic diseases, undiagnosed abnormal uterine bleeding, and other conditions such as breast cancer or liver disease[1][4].

Q: How does Yasmin compare to other oral contraceptives in terms of cost?

A: Yasmin and other DRSP-containing COCs tend to be more expensive than older generations of oral contraceptives[5].

Sources

1. Yasmin (drospirenone and ethinyl) tablet label - FDA.
2. In re Yasmin & Yaz (Drospirenone) Mktg. - Casetext.
3. Moleculin Reports Third Quarter 2024 Financial Results and Provides Corporate Update - PR Newswire.
4. Yasmin - accessdata.fda.gov - FDA.
5. Are Some Birth Control Pills Too Risky? - Center for Research on Women & Gender.