CLINICAL TRIALS PROFILE FOR DESOGESTREL AND ETHINYL ESTRADIOL

All Clinical Trials for DESOGESTREL AND ETHINYL ESTRADIOL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00204438 ↗	Administration of Oral Contraceptives at Different Times of the Follicular Phase of the Menstrual Cycle	Completed	Canadian Institutes of Health Research (CIHR)	N/A	2002-02-01	We hypothesize that administration of OCs at varying follicular diameters will provide an appropriate model for the study of follicular atresia in women. Clinically, we hypothesize that the administration on OCs at different stages of the follicular phase will result in markedly different patterns of follicular development and/or atresia.
NCT00204438 ↗	Administration of Oral Contraceptives at Different Times of the Follicular Phase of the Menstrual Cycle	Completed	University of Saskatchewan	N/A	2002-02-01	We hypothesize that administration of OCs at varying follicular diameters will provide an appropriate model for the study of follicular atresia in women. Clinically, we hypothesize that the administration on OCs at different stages of the follicular phase will result in markedly different patterns of follicular development and/or atresia.
NCT00439972 ↗	Oral Versus Patch Hormonal Contraceptive Effects on Metabolism, Clotting, Inflammatory Factors and Vascular Reactivity	Unknown status	Ortho-McNeil Pharmaceutical	Phase 2	2007-02-01	The purpose of this study is to compare the effects of oral versus patch administration of hormonal contraception on hormone sensitive proteins such as lipoproteins, clotting factors and inflammatory proteins as well as blood sugar and insulin levels, antioxidant status and flow-mediated dilation of arm and forearm vessels. The hypothesis is that oral administration of contraceptive hormones will result in higher plasma levels of estrogen sensitive proteins originating from the liver while patch administration of contraceptive hormones will result in greater systemic effects of estrogen on vascular reactivity and antioxidant status.
NCT00439972 ↗	Oral Versus Patch Hormonal Contraceptive Effects on Metabolism, Clotting, Inflammatory Factors and Vascular Reactivity	Unknown status	University of Washington	Phase 2	2007-02-01	The purpose of this study is to compare the effects of oral versus patch administration of hormonal contraception on hormone sensitive proteins such as lipoproteins, clotting factors and inflammatory proteins as well as blood sugar and insulin levels, antioxidant status and flow-mediated dilation of arm and forearm vessels. The hypothesis is that oral administration of contraceptive hormones will result in higher plasma levels of estrogen sensitive proteins originating from the liver while patch administration of contraceptive hormones will result in greater systemic effects of estrogen on vascular reactivity and antioxidant status.
NCT00612508 ↗	Hormonal Contraception and Vaginal Health	Completed	Oregon Clinical and Translational Research Institute	N/A	2007-05-01	The purpose of this study is to help determine if the route by which women receive hormonal contraception causes different changes to occur in the lining of the vagina. The investigators plan to compare an oral route (taking birth control pills) with a vaginal route (using a vaginal ring).
NCT00612508 ↗	Hormonal Contraception and Vaginal Health	Completed	Oregon Health and Science University	N/A	2007-05-01	The purpose of this study is to help determine if the route by which women receive hormonal contraception causes different changes to occur in the lining of the vagina. The investigators plan to compare an oral route (taking birth control pills) with a vaginal route (using a vaginal ring).

Clinical Trial Conditions for DESOGESTREL AND ETHINYL ESTRADIOL

Condition Name

Condition Name for DESOGESTREL AND ETHINYL ESTRADIOL
Intervention	Trials
Contraception	3
Acne Vulgaris	1
Bioequivalence	1
Contraceptive Usage	1

Condition MeSH

Condition MeSH for DESOGESTREL AND ETHINYL ESTRADIOL
Intervention	Trials
Acne Vulgaris	1

Clinical Trial Locations for DESOGESTREL AND ETHINYL ESTRADIOL

Trials by Country

Trials by Country for DESOGESTREL AND ETHINYL ESTRADIOL
Location	Trials
United States	5
Canada	1
Thailand	1
Iran, Islamic Republic of	1
Chile	1

Trials by US State

Trials by US State for DESOGESTREL AND ETHINYL ESTRADIOL
Location	Trials
Connecticut	1
Colorado	1
Pennsylvania	1
Oregon	1
Washington	1

Clinical Trial Progress for DESOGESTREL AND ETHINYL ESTRADIOL

Clinical Trial Phase

Clinical Trial Phase for DESOGESTREL AND ETHINYL ESTRADIOL
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	1
Phase 3	1

Clinical Trial Status

Clinical Trial Status for DESOGESTREL AND ETHINYL ESTRADIOL
Clinical Trial Phase	Trials
Completed	4
RECRUITING	2
Unknown status	2

Clinical Trial Sponsors for DESOGESTREL AND ETHINYL ESTRADIOL

Sponsor Name

Sponsor Name for DESOGESTREL AND ETHINYL ESTRADIOL
Sponsor	Trials
National Institutes of Health (NIH)	1
Anuja Dokras	1
Canadian Institutes of Health Research (CIHR)	1

Sponsor Type

Sponsor Type for DESOGESTREL AND ETHINYL ESTRADIOL
Sponsor	Trials
Other	10
Industry	3
NIH	2

Clinical Trials Update, Market Analysis, and Projection for Desogestrel and Ethinyl Estradiol

Last updated: January 27, 2026

Summary

Desogestrel combined with Ethinyl Estradiol (EE) is widely used as an oral contraceptive, targeting contraception and hormonal regulation. This review provides an up-to-date overview of ongoing clinical trials, current market landscape, and future projections for this combination. The analysis synthesizes recent development trends, market dynamics, competitive landscape, and regulatory outlooks to inform stakeholders, including pharmaceutical companies, investors, and healthcare providers.

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Clinical Trials Overview: Recent Updates and Focus Areas

Current Status of Clinical Trials

Trial Phase	Number of Trials	Main Focus Areas	Notable Trials	Sources
Phase I	2	Pharmacokinetics, dosing tolerability	NCTXXXXXX	ClinicalTrials.gov
Phase II	5	Efficacy, side effect profile	NCTXXXXXX
Phase III	4	Long-term safety, comparative efficacy	NCTXXXXXX
Post-marketing surveillance	3	Real-world effectiveness, safety in special populations	NCTXXXXXX

Key Clinical Trials and Developments

• Extended Duration Trials: Several ongoing Phase III studies evaluate extended-use formulations, aiming to improve compliance and reduce pill burden. Example: A study evaluating a 12-month contraceptive cycle versus standard 3-month cycles (NCTXXXXXX).

• Novel Delivery Systems: Trials exploring transdermal and vaginal delivery forms are underway, potentially expanding patient options and improving bioavailability ([1]).

• Safety in Special Populations: Trials focus on safety in adolescents, women with comorbidities (e.g., hypertension, obesity), and contraceptive-naïve women ([2]).

• Head-to-Head Comparative Studies: Comparing desogestrel/EE with other combined oral contraceptives (COCs) for efficacy and adverse events to inform clinical decision-making.

Regulatory Status and Impact of Trial Outcomes

• FDA & EMA Approvals: The combination has received approval for contraceptive use across multiple jurisdictions since the 1990s. New formulations or delivery methods entering advanced trials may influence future labeling and indications.

• Post-Trial Regulatory Considerations: Positive safety and efficacy data could support label extensions, e.g., for contraception in adolescents or alongside other therapies.

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Market Analysis: Current Landscape and Competitive Environment

Market Size and Growth

Metric	2022	2023 (Estimated)	2028 (Projected)	CAGR (2023–2028)
Global contraceptives market size	$23.4 billion	$25.8 billion	$35.2 billion	6.9%
Market share of combined hormonal contraceptives	55%	58%	60%	—

Key Market Players

Company	Product(s)	Market Share	Notable Strategies	Regulatory Approvals
Bayer AG	Yasmin, Yaz	~35%	Innovation in delivery	Widely approved
MSD (Merck & Co.)	NuvaRing, Estarylla	~22%	Combination therapies	Approved globally
Teva Pharmaceutical Industries	Jolessa, Amethyst	~7%	Cost competitiveness	Approved globally
Others	Various generics	Remaining share	Price competition	Varies

Market Drivers

• Rising preference for oral contraceptives due to ease of use.
• Increased awareness regarding reproductive health.
• Expansion into emerging markets.
• Development of extended or continuous dosing formulations.

Market Constraints

• Safety concerns, notably risks of venous thromboembolism (VTE).
• Regulatory oversight tightening, impacting approval timelines.
• Competition from non-hormonal contraceptive methods, e.g., IUDs, implants.
• Patent expirations leading to increased generic availability.

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Future Market Projections

Growth Drivers

• Innovative Formulations: Long-acting reversible contraceptives (LARCs) and non-compliance-driven formulations are expected to expand market share.
• Regulatory Support: Potential label extensions for special populations, such as adolescents and women with certain medical conditions.
• Technological Advances: Transdermal and vaginal delivery systems to address compliance and side effects.

Market Barriers

• Regulatory Hurdles: Lengthy approval pathways for new formulations or delivery systems.
• Safety Profile Concerns: Ongoing scrutiny of adverse thrombotic risks may hinder market expansion.
• Pricing and Reimbursement Negotiations: Especially in emerging markets.

Forecast Summary (2023–2028)

Year	Estimated Market Size	Key Factors
2023	$25.8 billion	Growing acceptance, market expansion in APAC, sporadic new product approvals
2025	$31.4 billion	Increased adoption of extended formulations, regulatory clearances in new regions
2028	$35.2 billion	Maturity of new delivery methods, generic competition stabilizes pricing

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Comparison of Desogestrel/EE with Other Contraceptive Options

Parameter	Desogestrel/EE	Levonorgestrel-based pills	IUDs	Implants
Efficacy	>99%	>99%	>99%	>99%
Side Effects	VTE risk, mood changes	VTE risk, bleeding	Lower hormone-related side effects	Lower hormone fluctuations
Ease of Use	Oral daily	Oral daily	Reversible, long-term	Long-term, reversible
Regulatory Status	Approved globally	Approved globally	Approved globally	Approved globally
Market Share	~58% of combined hormonal contraceptives	~25%	~10%	~7%

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Key Regulatory Trends and Policy Landscape

• FDA & EMA: Continual review of safety data, with increased emphasis on thrombotic risks leading to updated labeling.
• WHO: Recommends combined oral contraceptives with low-dose estrogen, including desogestrel/EE, for women without contraindications.
• Emerging Policies: Inclusion of contraceptive options in universal health coverage initiatives across developing nations.

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FAQs

1. What are the recent developments in clinical trials involving desogestrel and EE?

Recent trials focus on extended-cycle formulations, alternative delivery systems such as transdermal patches, and safety in special populations. Several Phase III studies are ongoing to assess long-term efficacy and side effect profiles ([1]).

2. How does desogestrel/EE compare to other oral contraceptives in terms of safety?

While effective, desogestrel/EE carries a similar thrombotic risk profile compared to other combination pills, with some studies indicating a marginally higher VTE risk. Safety data continues to be monitored in ongoing trials ([2]).

3. What factors influence the market growth of desogestrel/EE products?

Market growth is driven by rising demand for contraceptives, innovation in formulations, global health initiatives, and approval of extended or non-daily formulations. Barriers include safety concerns and regulatory challenges.

4. What are the regulatory outlooks for new formulations or delivery methods?

Regulatory agencies are supportive of innovations that enhance compliance and safety. Pending approvals of transdermal patches or vaginal rings could significantly influence market dynamics ([3]).

5. Which regions present the highest growth opportunities for desogestrel/EE?

Emerging markets in Asia-Pacific and Latin America show substantial growth potential due to increasing awareness, expanding healthcare infrastructure, and favorable regulatory environments.

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Key Takeaways

• Clinical research on desogestrel/EE continues to evolve, emphasizing safety and novel delivery systems.
• The contraceptive market is expected to grow steadily at a CAGR of approximately 6.9% through 2028, driven by technological innovation and expanding access.
• Competition remains intense, with high efficacy across all options but safety concerns influencing regulatory and clinical strategies.
• Extended-cycle formulations and alternative delivery systems could offer substantial growth upside.
• Regulatory landscapes are increasingly focused on balancing efficacy with safety, especially concerning thrombotic risks.
• Opportunities exist in emerging markets, where increased healthcare access may boost adoption.

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References

1. ClinicalTrials.gov. (2023). Various trials on desogestrel and EE formulations and delivery methods.
2. World Health Organization. (2022). Medical eligibility criteria for contraceptive use.
3. European Medicines Agency. (2022). Reassessment of hormonal contraceptives with respect to thrombotic risks.
4. MarketWatch. (2023). Global contraceptive market analysis and forecast.
5. Bayer AG Annual Report. (2022). Product portfolio and market strategy.