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Last Updated: February 16, 2025

CLINICAL TRIALS PROFILE FOR LEVONORGESTREL


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All Clinical Trials for Levonorgestrel

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00064766 ↗ Norplant and Irregular Bleeding/Spotting Unknown status Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 4 2003-02-01 Irregular or prolonged menstrual bleeding and/or spotting are common side effects in patients using progestin-only hormonal contraception such as levonorgestrel implants (Norplant). Doxycycline, a drug approved by the Food and Drug Administration (FDA) to treat gum disease, may reduce the occurrence of uterine bleeding and spotting in women who use Norplant. This study will evaluate the effects of doxycycline on uterine bleeding/spotting in women using Norplant.
NCT00117273 ↗ A Study to Evaluate Suppression of the Pituitary-Ovarian Axis With Three Different Oral Contraceptive Regimens Completed Duramed Research Phase 3 2005-06-01 This is a randomized, open-label study to evaluate pituitary ovarian suppression in healthy, reproductive-aged women using three different regimens of oral contraceptives (OCs). Two extended regimen OCs, Seasonale (levonorgestrel/ethinyl estradiol 0.15/0.03 mg for 84 days followed by 7 days of placebo), and Seasonique (levonorgestrel/ethinyl estradiol 0.15/0.03 mg for 84 days followed by 7 days of ethinyl estradiol 0.01 mg), and a 28-day regimen OC, Portia (levonorgestrel/ethinyl estradiol 0.15/0.03 mg for 21 days followed by 7 days of placebo).
NCT00128934 ↗ Study Evaluating Combination of Levonorgestrel (LNG) and Ethinyl Estradiol (EE) in Premenstrual Dysphoric Disorder Completed Wyeth is now a wholly owned subsidiary of Pfizer Phase 3 2005-08-01 The purpose of this study is to determine whether levonorgestrel (LNG)/ethinyl estradiol (EE) is effective in treating the symptoms of severe premenstrual syndrome (PMS).
NCT00131885 ↗ Effects of St. John's Wort on the Oral Contraceptive Hormone Levonorgestrel Completed National Center for Complementary and Integrative Health (NCCIH) Phase 4 2005-08-01 This study will determine the effects of St. John's wort, a common herbal remedy, on metabolism of the female contraceptive hormone levonorgestrel.
NCT00131885 ↗ Effects of St. John's Wort on the Oral Contraceptive Hormone Levonorgestrel Completed University of Utah Phase 4 2005-08-01 This study will determine the effects of St. John's wort, a common herbal remedy, on metabolism of the female contraceptive hormone levonorgestrel.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Levonorgestrel

Condition Name

Condition Name for Levonorgestrel
Intervention Trials
Contraception 80
Healthy 21
HIV 11
Endometriosis 10
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Condition MeSH

Condition MeSH for Levonorgestrel
Intervention Trials
Hemorrhage 18
Emergencies 18
Hyperplasia 15
Endometrial Hyperplasia 13
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Clinical Trial Locations for Levonorgestrel

Trials by Country

Trials by Country for Levonorgestrel
Location Trials
United States 447
Germany 62
Canada 30
China 24
Japan 19
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Trials by US State

Trials by US State for Levonorgestrel
Location Trials
Pennsylvania 25
California 24
Florida 23
Colorado 23
Ohio 22
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Clinical Trial Progress for Levonorgestrel

Clinical Trial Phase

Clinical Trial Phase for Levonorgestrel
Clinical Trial Phase Trials
Phase 4 54
Phase 3 40
Phase 2/Phase 3 10
[disabled in preview] 35
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Clinical Trial Status

Clinical Trial Status for Levonorgestrel
Clinical Trial Phase Trials
Completed 163
Recruiting 28
Not yet recruiting 24
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Clinical Trial Sponsors for Levonorgestrel

Sponsor Name

Sponsor Name for Levonorgestrel
Sponsor Trials
Bayer 40
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 15
Boehringer Ingelheim 9
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Sponsor Type

Sponsor Type for Levonorgestrel
Sponsor Trials
Other 227
Industry 133
NIH 33
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Levonorgestrel: Clinical Trials, Market Analysis, and Projections

Introduction

Levonorgestrel, a synthetic progestin hormone, is widely used in various contraceptive methods, including oral contraceptive pills, injectables, and intrauterine devices (IUDs). This article provides an update on ongoing clinical trials, market analysis, and future projections for levonorgestrel.

Clinical Trials Update

Pharmacokinetics Study

A recent clinical trial conducted by AstraZeneca (Study identifier: D6970C00006) aims to assess the effect of multiple doses of baxdrostat on the pharmacokinetics of single doses of combined oral ethinyl estradiol and levonorgestrel in healthy female participants. This open-label, fixed sequence study involves three periods: the first period where participants receive a single dose of ethinyl estradiol/levonorgestrel (EE/LNG), the second period where participants self-administer baxdrostat daily, and the third period where participants receive both baxdrostat and EE/LNG. This study is crucial for understanding potential drug interactions and their impact on contraceptive efficacy[1].

Fertility Preservation in Endometrial Cancer

Another significant clinical trial, scheduled to enroll 264 patients between January 2025 and December 2025, evaluates the combined effect of a levonorgestrel-releasing intrauterine device (LNG-IUD), metformin, and liraglutide for fertility preservation in women with endometrial cancer. This randomized clinical trial aims to assess the efficacy and safety of this combination in treating atypical endometrial hyperplasia and early endometrial carcinoma while preserving fertility[4].

Market Analysis

Global Market Size and Growth

The global levonorgestrel market is anticipated to experience steady growth over the coming years. According to Cognitive Market Research, the market size is expected to reach $84.35 million by 2029, with a compound annual growth rate (CAGR) of 3.94% from 2023 to 2030[2].

InsightAce Analytic reports that the levonorgestrel API market was valued at USD 52.01 million in 2023 and is predicted to reach USD 71.37 million by 2031, growing at a CAGR of 4.13% during the forecast period. The short-acting contraceptive API segment is expected to hold a major global market share due to the widespread use of oral contraceptive pills and injectables[3].

Regional Market Performance

The North American levonorgestrel API market is expected to register the highest revenue share in the near future, driven by a robust healthcare system and increasing healthcare costs. The Asia Pacific region is also projected to grow rapidly due to a large female population, stringent contraceptive policies, and fertility rates[3].

Key Drivers and Challenges

The levonorgestrel market is driven by increasing awareness and utilization of contraceptives, particularly among younger populations. However, market growth is hampered by high safety and health costs associated with levonorgestrel API production, as well as supply chain disruptions caused by the COVID-19 pandemic[3].

Competitive Landscape

Top companies operating in the levonorgestrel market include Bayer, Paladin Labs, Foundation Consumer Healthcare, Theramex (Teva), Pfizer, Apotex, and HRA Pharma. These companies play a significant role in the development, manufacturing, and distribution of levonorgestrel-based products[5].

Market Projections

Forecasted Market Size

By 2032, the global levonorgestrel market is projected to touch USD 0.068 billion, with a CAGR of 3.3% during the forecast period. This growth is driven by increasing awareness and utilization of levonorgestrel during menopause and for contraceptive purposes[5].

Segment Growth

The short-acting contraceptive API segment is expected to continue dominating the market due to its convenience and effectiveness. The hormone-releasing IUD segment is also anticipated to witness rapid growth, particularly in regions like the US, Germany, the UK, China, and India, where these devices are widely used for both contraceptive and therapeutic purposes[3].

Key Takeaways

  • Clinical Trials: Ongoing trials focus on pharmacokinetics and drug interactions, as well as fertility preservation in endometrial cancer.
  • Market Size: The global levonorgestrel market is expected to reach $84.35 million by 2029 and $71.37 million by 2031 for the API market.
  • Growth Rate: The market is projected to grow at a CAGR of 3.94% to 4.13% during the forecast periods.
  • Regional Performance: North America and the Asia Pacific region are key markets due to robust healthcare systems and demographic factors.
  • Drivers and Challenges: Increasing awareness and utilization drive the market, while high production costs and supply chain disruptions pose challenges.
  • Competitive Landscape: Major pharmaceutical companies are key players in the levonorgestrel market.

FAQs

1. What is the expected global market size of levonorgestrel by 2029?

The global levonorgestrel market is expected to reach $84.35 million by 2029[2].

2. What is the CAGR of the levonorgestrel API market from 2023 to 2031?

The levonorgestrel API market is expected to grow at a CAGR of 4.13% from 2023 to 2031[3].

3. Which segment is expected to hold the major global market share in the levonorgestrel market?

The short-acting contraceptive API segment is expected to hold a major global market share due to the widespread use of oral contraceptive pills and injectables[3].

4. What are the key drivers of the levonorgestrel market?

Increasing awareness and utilization of contraceptives, particularly among younger populations, drive the levonorgestrel market[5].

5. Which region is expected to dominate the global levonorgestrel API market?

The North American levonorgestrel API market is expected to register the highest revenue share in the near future, followed by rapid growth in the Asia Pacific region[3].

Sources

  1. AstraZeneca Clinical Trials: "An Open-label, Fixed Sequence Study to Assess the Effect of Multiple Doses of Baxdrostat on the Pharmacokinetics of Single Doses of Combined Oral Ethinyl Estradiol and Levonorgestrel in Healthy Female Participants of Non-childbearing Potential."
  2. Cognitive Market Research: "Global Levonorgestrel Market Report."
  3. InsightAce Analytic: "Levonorgestrel API Market."
  4. MDPI: "Protocol for a Randomized Clinical Trial - Comprehensive Evaluation of a Levonorgestrel Intrauterine Device (LNG-IUD), Metformin, and Liraglutide for Fertility Preservation in Endometrial Cancer."
  5. Business Research Insights: "Levonorgestrel Market Size, Share | Analysis Report, 2032."

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