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Last Updated: February 8, 2025

CLINICAL TRIALS PROFILE FOR CLIMARA PRO


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505(b)(2) Clinical Trials for Climara Pro

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT00649896 ↗ Evaluation of Adhesion Quality of a New Formulation of the Mylan Estradiol Transdermal System 0.025 mg/Day and Climara® Transdermal System 0.025 mg/Day Completed Mylan Pharmaceuticals Phase 1 2003-08-01 The primary objective of this study was to compare the adhesive quality of a new formulation of the Mylan Estradiol Transdermal System with that of Climara® Transdermal System following a single system application in 80 healthy postmenopausal female volunteers. As a secondary objective, primary dermal irritation was assessed after removal of each transdermal system.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Climara Pro

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00154180 ↗ Kronos Early Estrogen Prevention Study (KEEPS) Unknown status Albert Einstein College of Medicine Phase 4 2005-09-01 The study will examine the effects of estrogen and progesterone on the development of atherosclerosis in menopausal women when hormone treatment is initiated within 3 years of the menopausal transition.
NCT00154180 ↗ Kronos Early Estrogen Prevention Study (KEEPS) Unknown status Albert Einstein College of Medicine of Yeshiva University Phase 4 2005-09-01 The study will examine the effects of estrogen and progesterone on the development of atherosclerosis in menopausal women when hormone treatment is initiated within 3 years of the menopausal transition.
NCT00154180 ↗ Kronos Early Estrogen Prevention Study (KEEPS) Unknown status Brigham and Women's Hospital Phase 4 2005-09-01 The study will examine the effects of estrogen and progesterone on the development of atherosclerosis in menopausal women when hormone treatment is initiated within 3 years of the menopausal transition.
NCT00154180 ↗ Kronos Early Estrogen Prevention Study (KEEPS) Unknown status Columbia University Phase 4 2005-09-01 The study will examine the effects of estrogen and progesterone on the development of atherosclerosis in menopausal women when hormone treatment is initiated within 3 years of the menopausal transition.
NCT00154180 ↗ Kronos Early Estrogen Prevention Study (KEEPS) Unknown status Mayo Clinic Phase 4 2005-09-01 The study will examine the effects of estrogen and progesterone on the development of atherosclerosis in menopausal women when hormone treatment is initiated within 3 years of the menopausal transition.
NCT00154180 ↗ Kronos Early Estrogen Prevention Study (KEEPS) Unknown status University of California, San Francisco Phase 4 2005-09-01 The study will examine the effects of estrogen and progesterone on the development of atherosclerosis in menopausal women when hormone treatment is initiated within 3 years of the menopausal transition.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Climara Pro

Condition Name

Condition Name for Climara Pro
Intervention Trials
Suicidal Ideation 3
Healthy 2
Aging 2
Depression 2
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Condition MeSH

Condition MeSH for Climara Pro
Intervention Trials
Suicidal Ideation 3
Depressive Disorder 3
Depression 3
Suicide 2
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Clinical Trial Locations for Climara Pro

Trials by Country

Trials by Country for Climara Pro
Location Trials
United States 33
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Trials by US State

Trials by US State for Climara Pro
Location Trials
North Carolina 5
Colorado 5
New York 4
Massachusetts 4
Illinois 3
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Clinical Trial Progress for Climara Pro

Clinical Trial Phase

Clinical Trial Phase for Climara Pro
Clinical Trial Phase Trials
Phase 4 10
Phase 3 1
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Climara Pro
Clinical Trial Phase Trials
Completed 16
Not yet recruiting 3
Recruiting 2
[disabled in preview] 6
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Clinical Trial Sponsors for Climara Pro

Sponsor Name

Sponsor Name for Climara Pro
Sponsor Trials
University of Colorado, Denver 6
National Institute of Mental Health (NIMH) 6
University of North Carolina, Chapel Hill 4
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Sponsor Type

Sponsor Type for Climara Pro
Sponsor Trials
Other 41
NIH 13
Industry 1
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Climara Pro: A Comprehensive Review of Clinical Trials, Market Analysis, and Projections

Introduction

Climara Pro, a transdermal patch containing the hormones estradiol and levonorgestrel, is a significant player in the hormone replacement therapy (HRT) market, particularly for menopausal women. This article delves into the clinical trials, market analysis, and future projections for Climara Pro.

Clinical Trials Overview

Efficacy in Reducing Vasomotor Symptoms

Clinical trials have demonstrated the efficacy of Climara Pro in reducing moderate to severe hot flushes and night sweats associated with menopause. At week 12, Climara Pro showed a 90% reduction in the mean number of moderate to severe hot flushes from baseline, compared to a 48% reduction in the placebo group[1].

Reduction in Hot Flush Severity

The severity of hot flushes was also significantly reduced. By week 12, the treatment group experienced an 82% reduction in the mean severity of hot flushes, whereas the placebo group saw only a 26% reduction[1].

Pharmacokinetics and Wearability

Studies have shown that the Climara Pro patch delivers estradiol consistently for a full 7 days, with no drug accumulation and a maintained physiologic estrone to estradiol ratio. The patch has excellent adhesion and is well-tolerated, although some patients experienced adverse skin reactions[4].

Indications and Usage

Treatment of Vasomotor Symptoms

Climara Pro is indicated for the treatment of moderate to severe vasomotor symptoms (hot flashes and night sweats) in postmenopausal women with a healthy uterus[5].

Prevention of Postmenopausal Osteoporosis

It is also approved for the prevention of postmenopausal osteoporosis in women with a healthy uterus. The patch should be considered in light of other available therapies, and non-estrogen medications should be considered first for osteoporosis prevention[5].

Market Analysis

Market Position

Climara Pro holds a strong position in the HRT market due to its efficacy in treating menopausal symptoms and preventing osteoporosis. The combination of estradiol and levonorgestrel addresses both the need for estrogen replacement and the risk of endometrial hyperplasia in women with a healthy uterus[2].

Competitive Landscape

The HRT market is competitive, with various products offering different delivery methods (oral, transdermal, vaginal) and hormone combinations. Climara Pro's once-weekly transdermal application and balanced hormone delivery make it a preferred option for many patients and healthcare providers[2].

Patient Preferences

Patient preference for a once-weekly application and the convenience of a transdermal patch contribute to Climara Pro's market appeal. Additionally, the patch's excellent adhesion and minimal skin irritation compared to other transdermal systems enhance patient compliance[4].

Safety and Risk Considerations

Breast Cancer Risk

Estrogen-progestin combination therapy, such as Climara Pro, may increase the risk of invasive breast cancer, particularly with long-term use. Regular breast exams and mammograms are recommended to mitigate this risk[2].

Endometrial Cancer Risk

The inclusion of levonorgestrel in Climara Pro helps balance the effects of estradiol on the uterine lining, reducing the risk of endometrial cancer compared to estrogen-only therapy. However, patients should be aware of warning signs such as unusual vaginal bleeding[2].

Cardiovascular Risks

Estrogen with or without progestin therapy should not be prescribed for primary or secondary prevention of cardiovascular events. The risks associated with cardiovascular events should be carefully considered when prescribing Climara Pro[3].

Market Projections

Growing Demand for HRT

The demand for HRT is expected to grow as the global population ages and more women enter menopause. Climara Pro, with its proven efficacy and convenience, is well-positioned to capture a significant share of this growing market.

Expanding Indications

Future clinical trials may explore additional indications for Climara Pro, such as the treatment of other menopausal symptoms or prevention of other postmenopausal health issues. This could further expand its market reach.

Regulatory Environment

Regulatory guidelines emphasize the use of the lowest effective dose and the shortest duration of HRT necessary. Climara Pro's once-weekly dosage and balanced hormone delivery align with these guidelines, which may support its continued market presence[5].

Key Takeaways

  • Efficacy in Vasomotor Symptoms: Climara Pro significantly reduces the frequency and severity of hot flushes and night sweats.
  • Market Position: Strong presence in the HRT market due to its balanced hormone delivery and convenience.
  • Safety Considerations: Increased risk of breast cancer and cardiovascular events; regular monitoring recommended.
  • Market Projections: Expected growth in demand for HRT and potential expansion of indications.

FAQs

What is Climara Pro used for?

Climara Pro is used for the treatment of moderate to severe vasomotor symptoms (hot flashes and night sweats) and the prevention of postmenopausal osteoporosis in women with a healthy uterus[5].

How is Climara Pro administered?

Climara Pro is administered as a once-weekly transdermal patch applied to the lower abdomen[5].

What are the potential risks associated with Climara Pro?

Potential risks include an increased risk of invasive breast cancer, endometrial cancer, and cardiovascular events. Regular monitoring and the shortest duration of therapy are recommended[2][3].

How effective is Climara Pro in reducing hot flushes?

Climara Pro reduces the mean number of moderate to severe hot flushes by 90% from baseline by week 12, significantly more than the placebo group[1].

Can Climara Pro be used by women without a uterus?

No, Climara Pro is specifically indicated for women with a healthy uterus due to the inclusion of levonorgestrel to balance the effects of estradiol on the uterine lining[5].

What are the common side effects of Climara Pro?

Common side effects include irregular vaginal bleeding or spotting, breast pain, and skin irritation where the patch is applied[2].

Sources

  1. Climara Pro Clinical Trials: Climara Pro® significantly reduced the severity of moderate to severe hot flushes at week 12 versus placebo. P<0.001 versus placebo[1].
  2. GoodRx - Climara Pro: Climara Pro is a patch that's applied to the skin once a week. It's approved to prevent osteoporosis in people who've gone through menopause[2].
  3. Bayer - CLIMARA English Product Monograph: The relief of menopausal and postmenopausal symptoms occurring in naturally or surgically induced estrogen deficiency[3].
  4. PubMed - Clinical experience with a seven-day estradiol transdermal system: The Climara patch delivers estradiol for a full 7 days. Clinical efficacy of both patch sizes is comparable with currently accepted therapy[4].
  5. Drugs.com - Climara Pro: Climara Pro is an estrogen plus progestin indicated in a woman with a uterus for the prevention of postmenopausal osteoporosis and treatment of moderate to severe vasomotor symptoms[5].

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