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Last Updated: February 12, 2025

CLINICAL TRIALS PROFILE FOR NORETHINDRONE ACETATE


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All Clinical Trials for Norethindrone Acetate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000897 ↗ A Study to Evaluate the Effects of Different Methods of Birth Control on the Drug Actions of Zidovudine (an Anti-HIV Drug) in HIV-Positive Women and to Compare Zidovudine Metabolism in Men and Women Completed National Institute of Allergy and Infectious Diseases (NIAID) N/A 1969-12-31 The purpose of this study is to look at the effects of different methods of birth control (oral and injectable) on how the body absorbs, makes available, and removes zidovudine (ZDV). This study will also evaluate the differences in men and women in how the body absorbs, makes available, and removes ZDV. Past research has shown that the effectiveness of ZDV as an anti-HIV drug might be decreased in individuals who use certain methods of birth control. ZDV may also have different effects in men compared to women.
NCT00003771 ↗ Hormone Replacement Therapy and the Risk of Breast Cancer Recurrence in Women With Previous Early Stage Breast Cancer Completed European Organisation for Research and Treatment of Cancer - EORTC Phase 3 1997-09-01 RATIONALE: Hormone replacement therapy is effective for relieving symptoms of menopause. It is not yet known if hormone replacement therapy increases the risk of breast cancer recurrence in women previously treated for early stage breast cancer. PURPOSE: Randomized phase III trial to determine the risk of breast cancer recurrence in women with previous early stage breast cancer who are receiving hormone replacement therapy for menopause symptoms.
NCT00003771 ↗ Hormone Replacement Therapy and the Risk of Breast Cancer Recurrence in Women With Previous Early Stage Breast Cancer Completed International Breast Cancer Study Group Phase 3 1997-09-01 RATIONALE: Hormone replacement therapy is effective for relieving symptoms of menopause. It is not yet known if hormone replacement therapy increases the risk of breast cancer recurrence in women previously treated for early stage breast cancer. PURPOSE: Randomized phase III trial to determine the risk of breast cancer recurrence in women with previous early stage breast cancer who are receiving hormone replacement therapy for menopause symptoms.
NCT00003771 ↗ Hormone Replacement Therapy and the Risk of Breast Cancer Recurrence in Women With Previous Early Stage Breast Cancer Completed Scandinavian Breast Group Phase 3 1997-09-01 RATIONALE: Hormone replacement therapy is effective for relieving symptoms of menopause. It is not yet known if hormone replacement therapy increases the risk of breast cancer recurrence in women previously treated for early stage breast cancer. PURPOSE: Randomized phase III trial to determine the risk of breast cancer recurrence in women with previous early stage breast cancer who are receiving hormone replacement therapy for menopause symptoms.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Norethindrone Acetate

Condition Name

Condition Name for Norethindrone Acetate
Intervention Trials
Endometriosis 12
Heavy Menstrual Bleeding 9
Uterine Fibroids 7
Contraception 7
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Condition MeSH

Condition MeSH for Norethindrone Acetate
Intervention Trials
Endometriosis 15
Hemorrhage 13
Menorrhagia 12
Leiomyoma 12
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Clinical Trial Locations for Norethindrone Acetate

Trials by Country

Trials by Country for Norethindrone Acetate
Location Trials
United States 493
Poland 38
Canada 25
Hungary 23
South Africa 18
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Trials by US State

Trials by US State for Norethindrone Acetate
Location Trials
Florida 23
California 22
Texas 21
Virginia 19
Washington 19
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Clinical Trial Progress for Norethindrone Acetate

Clinical Trial Phase

Clinical Trial Phase for Norethindrone Acetate
Clinical Trial Phase Trials
Phase 4 3
Phase 3 27
Phase 2 4
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Clinical Trial Status

Clinical Trial Status for Norethindrone Acetate
Clinical Trial Phase Trials
Completed 28
Recruiting 8
Unknown status 4
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Clinical Trial Sponsors for Norethindrone Acetate

Sponsor Name

Sponsor Name for Norethindrone Acetate
Sponsor Trials
Myovant Sciences GmbH 12
AbbVie 6
Milton S. Hershey Medical Center 4
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Sponsor Type

Sponsor Type for Norethindrone Acetate
Sponsor Trials
Industry 33
Other 28
NIH 5
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Norethindrone Acetate: Clinical Trials, Market Analysis, and Projections

Introduction

Norethindrone acetate, a synthetic progestin, is a crucial component in various hormonal therapies, including oral contraceptives, hormone replacement therapy (HRT), and treatments for endometriosis and abnormal uterine bleeding. This article delves into the current state of clinical trials, market analysis, and future projections for norethindrone acetate.

Clinical Trials and Research

Menstrual Suppression

Clinical trials have focused on the efficacy of norethindrone acetate in menstrual suppression. For instance, studies comparing continuous and cyclic use of combined oral contraceptives (OCPs) containing norethindrone acetate have shown that continuous use leads to higher rates of amenorrhea. A randomized trial involving 323 women on continuous LNG 90 micrograms/ethinyl estradiol 20 micrograms and 318 women on cyclic LNG 100 micrograms/ethinyl estradiol 20 micrograms demonstrated that the incidence of no bleeding increased significantly over the study period in the continuous OCP group[1].

Pharmacokinetics and Bioavailability

A cross-sectional pilot study (NCT05294341) is examining the serial plasma concentrations of norethindrone and its acetate form. This study aims to assess the relative bioavailability, maximum and minimum concentrations, and differences in serum levels of estradiol, LH, FSH, and progesterone between individuals taking 5mg norethindrone acetate and 0.35mg norethindrone. The study highlights that norethindrone acetate has a prolonged half-life, contributing to its prolonged action[3].

Combination Therapies

Another clinical trial (EudraCT Number: 2018-001368-43) evaluated the long-term effects of relugolix 40 mg with estradiol 1.0 mg and norethindrone acetate 0.5 mg. This trial, completed in 2021, assessed the safety and efficacy of this combination therapy, indicating potential benefits in managing menopausal symptoms and other hormone-related conditions[4].

Market Analysis

Market Size and Growth

The global norethindrone acetate drug market is projected to grow at a compound annual growth rate (CAGR) of around 4% during the forecast period. This growth is driven by the increasing prevalence of menopausal and post-menopausal conditions among the aging global population[2].

Drivers and Opportunities

The primary driver for the market is the growing awareness and acceptance of HRT as an effective treatment for managing menopausal symptoms. HRT, which includes norethindrone acetate, provides relief from symptoms such as hot flashes, night sweats, and vaginal dryness, and may also offer benefits in maintaining bone health and reducing the risk of osteoporosis[2].

Diverse Formulations and Delivery Routes

The availability of diverse formulations and delivery routes, including oral, transdermal, and vaginal options, provides healthcare providers and patients with flexibility in treatment choices. This variety is expected to enhance patient convenience and adherence to therapy, particularly with the development of novel delivery mechanisms like transdermal patches and vaginal rings[2].

Market Projections

Future Outlook

The future outlook for the norethindrone acetate market remains positive, driven by the continued need for effective and well-tolerated HRT options. As the global population ages, the demand for norethindrone acetate and other HRT therapies is expected to remain high. The growing emphasis on personalized and tailored approaches to menopausal management presents significant opportunities for market growth[2].

Emerging Applications and Innovations

Ongoing research and clinical trials exploring the use of norethindrone acetate in combination with other therapies or for managing additional menopausal-related conditions could open up new avenues for the market. Innovations in delivery mechanisms and the potential for more targeted and localized delivery of active ingredients are expected to contribute to the market's expansion[2].

Access and Affordability

Initiatives aimed at improving access to HRT options, including norethindrone acetate, in underserved regions can create new growth opportunities. Efforts to develop more cost-effective formulations and implement reimbursement schemes can help expand the patient population and drive the adoption of norethindrone acetate in these regions[2].

Key Takeaways

  • Clinical Trials: Ongoing studies focus on the efficacy of norethindrone acetate in menstrual suppression and its pharmacokinetics, as well as its use in combination therapies.
  • Market Growth: The market is driven by the increasing prevalence of menopausal conditions and the growing acceptance of HRT.
  • Diverse Formulations: Various delivery routes enhance patient convenience and adherence.
  • Future Outlook: The market is expected to grow due to the aging population and the need for personalized HRT options.
  • Emerging Applications: Innovations in delivery mechanisms and new therapeutic applications are expected to expand the market.

FAQs

What is norethindrone acetate used for?

Norethindrone acetate is used in various hormonal therapies, including oral contraceptives, hormone replacement therapy (HRT), and treatments for endometriosis and abnormal uterine bleeding.

How does continuous use of norethindrone acetate affect menstrual bleeding?

Continuous use of norethindrone acetate can lead to higher rates of amenorrhea compared to cyclic use, although it may cause initial irregular bleeding or spotting that tends to decrease over successive cycles[1].

What are the key drivers of the norethindrone acetate market?

The primary drivers include the increasing prevalence of menopausal and post-menopausal conditions and the growing awareness and acceptance of HRT as an effective treatment option[2].

What are the potential side effects of norethindrone acetate?

While norethindrone acetate is generally well-tolerated, potential side effects include an increased risk of certain medical conditions. However, these risks can be managed with proper medical supervision[2].

How is the market for norethindrone acetate expected to grow in the future?

The market is expected to grow at a CAGR of around 4%, driven by the aging global population and the increasing demand for personalized and effective HRT options[2].

Sources

  1. American College of Obstetricians and Gynecologists (ACOG). General Approaches to Medical Management of Menstrual Suppression. Retrieved from https://www.acog.org/clinical/clinical-guidance/clinical-consensus/articles/2022/09/general-approaches-to-medical-management-of-menstrual-suppression
  2. DataHorizzon Research. Estradiol Norethindrone Acetate Drug Market Size, Share & Forecast. Retrieved from https://datahorizzonresearch.com/estradiol-norethindrone-acetate-drug-market-4938
  3. ClinicalTrials.gov. Metabolism of 0.35mg Norethindrone vs 5mg Norethindrone Acetate. Retrieved from https://cdn.clinicaltrials.gov/large-docs/41/NCT05294341/Prot_SAP_003.pdf
  4. EU Clinical Trials Register. To evaluate the long-term effect of relugolix 40 mg with estradiol 1.0 mg and norethindrone acetate 0.5 mg. Retrieved from https://www.clinicaltrialsregister.eu/ctr-search/trial/2018-001368-43/HU
  5. 360iResearch. Norethindrone Acetate API Market Size & Share 2025-2030. Retrieved from https://www.360iresearch.com/library/intelligence/norethindrone-acetate-api

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