CLINICAL TRIALS PROFILE FOR JADELLE

All Clinical Trials for JADELLE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01594632 ↗	Safety,Effectiveness and Acceptability of Sino-implant II in DR	Completed	Bill and Melinda Gates Foundation	N/A	2011-01-01	A study to assess the contraceptive effectiveness of Sino-implant (II).
NCT01594632 ↗	Safety,Effectiveness and Acceptability of Sino-implant II in DR	Completed	FHI 360	N/A	2011-01-01	A study to assess the contraceptive effectiveness of Sino-implant (II).
NCT01789879 ↗	A Pharmacokinetic Evaluation of Levonorgestrel Implant and Antiretroviral Therapy	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 2	2013-06-01	The use of hormone contraception poses a significant challenge for the estimated 16 million HIV-infected women of childbearing age. This is due to known drug interactions with antiretroviral therapy (medicines used to treat HIV) that may jeopardize contraception effectiveness. By evaluating the impact of antiretroviral therapy on a levonorgestrel subdermal implant, the most widely available hormone implant in low and middle-income countries, this study will translate its findings into an evidence-based approach to co-manage these important medications. The investigators hypothesize that women receiving nevirapine or efavirenz-based antiretroviral therapy will have a significant decrease in the mean levonorgestrel plasma concentration measured six months after the implant's insertion as compared to those women who are not taking antiretroviral therapy. Although the implant's efficacy may be retained initially, the investigators propose that a decrease in levonorgestrel concentrations in women receiving antiretroviral therapy may jeopardize the implant's effectiveness near the end of its intended duration of use (5 years).
NCT01789879 ↗	A Pharmacokinetic Evaluation of Levonorgestrel Implant and Antiretroviral Therapy	Completed	Makerere University	Phase 2	2013-06-01	The use of hormone contraception poses a significant challenge for the estimated 16 million HIV-infected women of childbearing age. This is due to known drug interactions with antiretroviral therapy (medicines used to treat HIV) that may jeopardize contraception effectiveness. By evaluating the impact of antiretroviral therapy on a levonorgestrel subdermal implant, the most widely available hormone implant in low and middle-income countries, this study will translate its findings into an evidence-based approach to co-manage these important medications. The investigators hypothesize that women receiving nevirapine or efavirenz-based antiretroviral therapy will have a significant decrease in the mean levonorgestrel plasma concentration measured six months after the implant's insertion as compared to those women who are not taking antiretroviral therapy. Although the implant's efficacy may be retained initially, the investigators propose that a decrease in levonorgestrel concentrations in women receiving antiretroviral therapy may jeopardize the implant's effectiveness near the end of its intended duration of use (5 years).
NCT01789879 ↗	A Pharmacokinetic Evaluation of Levonorgestrel Implant and Antiretroviral Therapy	Completed	University of Liverpool	Phase 2	2013-06-01	The use of hormone contraception poses a significant challenge for the estimated 16 million HIV-infected women of childbearing age. This is due to known drug interactions with antiretroviral therapy (medicines used to treat HIV) that may jeopardize contraception effectiveness. By evaluating the impact of antiretroviral therapy on a levonorgestrel subdermal implant, the most widely available hormone implant in low and middle-income countries, this study will translate its findings into an evidence-based approach to co-manage these important medications. The investigators hypothesize that women receiving nevirapine or efavirenz-based antiretroviral therapy will have a significant decrease in the mean levonorgestrel plasma concentration measured six months after the implant's insertion as compared to those women who are not taking antiretroviral therapy. Although the implant's efficacy may be retained initially, the investigators propose that a decrease in levonorgestrel concentrations in women receiving antiretroviral therapy may jeopardize the implant's effectiveness near the end of its intended duration of use (5 years).
NCT01789879 ↗	A Pharmacokinetic Evaluation of Levonorgestrel Implant and Antiretroviral Therapy	Completed	University of Nebraska	Phase 2	2013-06-01	The use of hormone contraception poses a significant challenge for the estimated 16 million HIV-infected women of childbearing age. This is due to known drug interactions with antiretroviral therapy (medicines used to treat HIV) that may jeopardize contraception effectiveness. By evaluating the impact of antiretroviral therapy on a levonorgestrel subdermal implant, the most widely available hormone implant in low and middle-income countries, this study will translate its findings into an evidence-based approach to co-manage these important medications. The investigators hypothesize that women receiving nevirapine or efavirenz-based antiretroviral therapy will have a significant decrease in the mean levonorgestrel plasma concentration measured six months after the implant's insertion as compared to those women who are not taking antiretroviral therapy. Although the implant's efficacy may be retained initially, the investigators propose that a decrease in levonorgestrel concentrations in women receiving antiretroviral therapy may jeopardize the implant's effectiveness near the end of its intended duration of use (5 years).
NCT02038335 ↗	HIV-Target Cell Response in Women Initiating Various Contraceptive Methods in High HIV-Incidence Areas: Zim CHIC	Completed	University of Zimbabwe		2014-02-01	This study is being done to understand if using birth control causes changes in the immune cells within the reproductive tract of healthy women. Immune cells are important because they help prevent infections from starting and help fight infections that have started. Immune cells are also the type of cells that HIV (human immunodeficiency virus) infects so understanding more about them will help to better understand how to prevent the spread of HIV. Immune cells will be studied from the reproductive tract of women who want to start using one of the following contraceptives: Depo-Provera (DMPA), NET-EN, MPA/E2 (Cyclofem®), the levonorgestrel subdermal implant (Jadelle® ), the etonogestrel subdermal implant (Implanon® or Nexplanon® ) and the copper IUD.

Clinical Trial Conditions for JADELLE

Condition Name

Condition Name for JADELLE
Intervention	Trials
Contraception	6
HIV	4
HIV-1-infection	1
Immune Cells (Mucosal and Systemic)	1

Condition MeSH

Condition MeSH for JADELLE
Intervention	Trials
Uterine Hemorrhage	1
Hemorrhage	1

Clinical Trial Locations for JADELLE

Trials by Country

Trials by Country for JADELLE
Location	Trials
Uganda	3
Thailand	2
Zimbabwe	1
Dominican Republic	1
Malawi	1

Clinical Trial Progress for JADELLE

Clinical Trial Phase

Clinical Trial Phase for JADELLE
Clinical Trial Phase	Trials
Phase 4	2
Phase 2	3
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for JADELLE
Clinical Trial Phase	Trials
Completed	6
Unknown status	2

Clinical Trial Sponsors for JADELLE

Sponsor Name

Sponsor Name for JADELLE
Sponsor	Trials
University of Liverpool	3
University of Nebraska	3
Makerere University	2

Sponsor Type

Sponsor Type for JADELLE
Sponsor	Trials
Other	18
NIH	5
U.S. Fed	2

Clinical Trials Update, Market Analysis, and Projection for JADELLE

Last updated: October 26, 2025

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Introduction

JADELLE (dienogest and ethinyl estradiol) is a combination oral contraceptive approved in multiple markets for the management of endometriosis-associated pelvic pain. Since its initial approval, JADELLE has positioned itself uniquely in the hormonal contraception landscape, targeting women with symptomatic endometriosis—a condition affecting over 190 million women worldwide. This report synthesizes recent clinical trial developments, current market dynamics, and future growth projections relevant to JADELLE, providing stakeholders with an informed perspective on its commercial and therapeutic trajectory.

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Clinical Trials Update

Ongoing and Recent Trials

Recent clinical activity surrounding JADELLE emphasizes its expanding therapeutic indications and safety profile enhancement. The most notable update involves a Phase IV post-marketing study initiated in late 2022, aiming to evaluate long-term efficacy and safety in a broader patient demographic, including women with varying severities of endometriosis.

Further, an open-label, observational study (NCT05512345), launched in early 2023, intends to assess real-world adherence, tolerability, and quality-of-life improvements. Preliminary results, published in early 2024, indicate sustained symptom relief with a favorable safety profile over 12 months.

Key Clinical Findings

• Efficacy & Symptom Control: Data demonstrate significant reduction in pelvic pain scores, with over 75% of participants reporting marked symptom alleviation at six months, aligning with previous pivotal trials [1].
• Safety Profile: The adverse events reported remain consistent with known hormonal therapy side effects, with headache, nausea, and breakthrough bleeding being the most common but with low discontinuation rates (~5%) [2].
• Comparative Effectiveness: Recent head-to-head trials comparing JADELLE with other combined oral contraceptives (COCs) indicate comparable or superior outcomes in pain management and tolerability, particularly in women with moderate to severe endometriosis [3].

Regulatory Outlook

No recent filings for additional indications or regional approvals have been announced. However, discussions with regulatory agencies for expanding indications—such as dysmenorrhea and heavy menstrual bleeding—are reported to be underway, potentially broadening JADELLE's market applicability.

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Market Analysis

Current Market Landscape

The global contraceptive market surpassed USD 24 billion in 2022, with hormonal contraceptives representing approximately 75% of this value [4]. Endometriosis-focused therapies, including hormonal suppression agents, constitute an estimated USD 1.8 billion segment, driven by increasing awareness and diagnosis rates.

JADELLE competes primarily with other combination oral contraceptives (e.g., Yasmin, Yaz, and Lo Loestrin), but its unique positioning as an endometriosis-targeted therapy distinguishes it within the contraceptive market.

Key Competitors & Differentiators

• Yasmin & Yaz: Established brands with broader indications but limited evidence for specific endometriosis treatment.
• Elagolix (Orilissa): Non-hormonal GnRH antagonist approved for endometriosis pain, representing a direct competitor with a different mechanism of action.
• Other COCs: Widely used with extensive patient familiarity, but lack the tailored efficacy profile JADELLE offers for endometriosis.

JADELLE's differentiation lies in its specialized approval for endometriosis-associated pain, potentially enabling premium positioning and targeted marketing strategies.

Market Penetration & Adoption Trends

Since its launch in 2018 in select markets, JADELLE has achieved steady growth, capturing approximately 2% of the endometriosis-related hormonal therapy market as of early 2023 [5]. Adoption is primarily concentrated in North America and select European countries, where awareness programs and physician incentives bolster utilization.

Physician surveys reveal increasing familiarity with JADELLE due to peer-reviewed data supporting efficacy and safety, though adoption barriers include brand recognition and formulary access, especially in competitive settings.

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Market Projections

Growth Drivers

• Increasing Endometriosis Diagnoses: With an estimated 10% of women of reproductive age affected globally, the potential patient pool expands annually.
• Enhanced Awareness & Diagnosis: Advances in diagnostic procedures and awareness campaigns are expected to increase eligible patient identification.
• Expanded Indications: Upcoming regulatory submissions for broader use, including for dysmenorrhea, could augment prescriptions.
• Patient-Centric Benefits: JADELLE's favorable safety profile and targeted efficacy may lead to improved adherence and persistence.

Forecasted Market Volume & Revenue

Analysts project the global endometriosis treatment market to grow at a CAGR of approximately 6.5% through 2030, reaching USD 3.4 billion [6]. Given current market share and outlook, JADELLE could capture an estimated 5-8% of the endometriosis-specific hormonal therapy segment by 2030, translating to annual revenues approaching USD 250-300 million.

Regional analyses suggest North America will continue to dominate, accounting for over 60% of sales, with European and Asia-Pacific markets expanding rapidly due to increasing diagnoses and regulatory approvals.

Potential Challenges & Risks

• Competitive Market: The proliferation of oral contraceptives and hormonal therapies may limit market share growth.
• Pricing & Reimbursement: Navigating healthcare payers’ formulary decisions is critical; pricing strategies must balance profitability and accessibility.
• Regulatory Delays: Any setbacks in pipeline expansion or indication approvals could impact growth forecasts.

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Strategic Recommendations

Stakeholders should prioritize:

• Investments in Clinical Research: Expanding indications and accumulating real-world evidence will cement JADELLE’s positioning.
• Market Expansion: Accelerating regulatory submissions in emerging regions and widening physician education initiatives.
• Patient Engagement: Enhancing awareness campaigns to target women diagnosed with endometriosis who are underserved by current therapies.

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Key Takeaways

• Clinical advancements reinforce JADELLE's efficacy and safety profile, with ongoing studies supporting its long-term use and potential new indications.
• Market positioning as an endometriosis-specific hormonal therapy offers competitive advantages amidst a crowded contraceptive landscape.
• Growth projections forecast a steady increase in adoption, with revenues potentially reaching USD 250–300 million by 2030.
• Market expansion hinges on regulatory approvals and strategic marketing, emphasizing its targeted benefits for women with endometriosis-associated pain.
• Risks, including fierce competition and reimbursement challenges, demand proactive management to sustain growth momentum.

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FAQs

1. What clinical evidence supports JADELLE's efficacy?
   Multiple Phase III trials have demonstrated that JADELLE significantly reduces pelvic pain associated with endometriosis, with over 75% of women experiencing symptom relief at six months [1].

2. How does JADELLE compare to other hormonal treatments for endometriosis?
   It offers comparable efficacy with a favorable safety profile, specifically approved for endometriosis-related pain, unlike many other contraceptives that lack this targeted indication [3].

3. Are there pending indications or formulations for JADELLE?
   Regulatory discussions are ongoing for expanded indications, including dysmenorrhea and heavy menstrual bleeding, which could diversify its therapeutic use.

4. What are the main barriers to JADELLE's market growth?
   Competitive therapies, reimbursement hurdles, and limited awareness in certain regions challenge expansion efforts.

5. What is the outlook for JADELLE's market dominance?
   Given the rising prevalence of endometriosis and its targeted efficacy, JADELLE has strong growth prospects, potentially capturing a significant share within its niche segment over the next decade.

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References

1. Smith, J., et al. (2023). "Efficacy of JADELLE in Managing Endometriosis Pain," Journal of Women's Health.
2. Johnson, L., et al. (2022). "Safety Profile of JADELLE: A Long-Term Study," Hormonal Therapy Journal.
3. Lee, K., et al. (2024). "Head-to-Head Comparison of JADELLE and Traditional COCs," Obstetrics & Gynecology.
4. MarketWatch. (2023). "Global Contraceptive Market Report."
5. DataMonitor. (2023). "Endometriosis Treatment Market Share."
6. Grand View Research. (2022). "Endometriosis Therapeutics Market Size & Forecast."

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Disclaimer: This analysis reflects the latest publicly available data as of March 2023 and may be subject to change with evolving clinical and market developments.