CLINICAL TRIALS PROFILE FOR CLIMARA

505(b)(2) Clinical Trials for CLIMARA

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.

All Clinical Trials for CLIMARA

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.
NCT00154180 ↗	Kronos Early Estrogen Prevention Study (KEEPS)	Unknown status	University of Utah	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.

Clinical Trial Conditions for CLIMARA

Condition Name

Condition Name for CLIMARA
Intervention	Trials
Suicidal Ideation	3
Depression	2
Menopause	2
Endothelial Dysfunction	2

Condition MeSH

Condition MeSH for CLIMARA
Intervention	Trials
Suicidal Ideation	3
Depressive Disorder	3
Depression	3
Suicide	2

Clinical Trial Locations for CLIMARA

Trials by Country

+

−

Trials by Country for CLIMARA
Location	Trials
United States	33

Trials by US State

+

−

Trials by US State for CLIMARA
Location	Trials
North Carolina	5
Colorado	5
New York	4
Massachusetts	4
Illinois	3

Clinical Trial Progress for CLIMARA

Clinical Trial Phase

Clinical Trial Phase for CLIMARA
Clinical Trial Phase	Trials
Phase 4	10
Phase 3	1
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for CLIMARA
Clinical Trial Phase	Trials
Completed	16
Not yet recruiting	3
Withdrawn	2

Clinical Trial Sponsors for CLIMARA

Sponsor Name

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

Sponsor Type

Sponsor Type for CLIMARA
Sponsor	Trials
Other	41
NIH	13
Industry	1

Clinical Trials, Market Analysis, and Projections for Climara

Introduction

Climara, a transdermal system delivering estradiol, is a significant player in the hormone replacement therapy (HRT) market, particularly for managing menopausal symptoms. Here, we will delve into the clinical trials, market analysis, and future projections for Climara.

Clinical Trials and Efficacy

Pharmacokinetics and Efficacy Studies

Clinical trials have demonstrated the efficacy and safety of Climara. Studies involving single- and multiple-dose administrations showed that Climara maintains sustained blood levels of estradiol for the full 7-day wear period without drug accumulation. The system also maintains a physiologic estrone to estradiol ratio[1].

Reduction in Vasomotor Symptoms

In randomized, double-blind, multicenter trials involving 603 women, Climara significantly reduced the frequency of hot flushes compared to placebo. The 0.1 mg/day patch showed a 74.6% reduction in hot flushes, while the 0.05 mg/day patch resulted in a 64.5% reduction. These reductions were comparable to those achieved with conjugated equine estrogens (Premarin)[1].

Adhesion and Skin Irritation

Climara demonstrated excellent adhesion and skin irritation profiles similar to or better than other transdermal systems like Estraderm. Adverse skin reactions were the primary reason for withdrawal from the studies, affecting 6.8% of subjects[1].

Market Analysis

Current Market Position

Climara is part of the broader HRT market, which has seen significant growth due to the increasing demand for effective treatments for menopausal symptoms. The market for HRT is driven by the growing awareness of menopausal health and the need for reliable, well-tolerated therapies.

Competitive Landscape

The HRT market is competitive, with various products including oral medications, patches, and vaginal rings. Climara's unique selling point is its 7-day wear period and the use of new drug-in-adhesive technology, which enhances patient compliance and comfort[1].

Market Projections

Growth Drivers

The HRT market, including Climara, is expected to grow driven by several factors:

• Increasing Demand: Growing awareness and diagnosis of menopausal symptoms will drive the demand for HRT products.
• Aging Population: The global population is aging, leading to an increase in the number of women entering menopause.
• Advancements in Technology: Improvements in drug delivery systems, such as transdermal patches, will continue to attract patients seeking convenient and effective treatments.

Market Size and Forecast

While specific market size projections for Climara alone are not available, the broader HRT market is expected to see significant growth. The global HRT market is anticipated to expand as more women seek treatment for menopausal symptoms, driven by increased awareness and advancements in treatment options.

Regional Trends

Global Expansion

The demand for HRT products is expected to rise globally, with significant growth anticipated in regions with aging populations and improving healthcare infrastructure. For instance, the Asia-Pacific region is seeing a rise in clinical trials and healthcare investments, which could positively impact the HRT market[3].

Key Takeaways

• Efficacy and Safety: Climara has been shown to be effective in reducing vasomotor symptoms with a good safety profile.
• Market Position: Climara is a competitive player in the HRT market, known for its 7-day wear period and advanced drug delivery technology.
• Growth Drivers: The market is driven by increasing demand, an aging population, and technological advancements.
• Regional Trends: Global expansion, particularly in the Asia-Pacific region, is expected to contribute to market growth.

FAQs

What is Climara used for?

Climara is used for the treatment of moderate to severe vasomotor symptoms associated with menopause.

How effective is Climara in reducing hot flushes?

Climara has been shown to reduce the frequency of hot flushes by 64.5% to 74.6% depending on the dosage, compared to placebo[1].

What are the common side effects of Climara?

Common side effects include skin irritation and adverse skin reactions, which led to withdrawal from studies in 6.8% of subjects[1].

How does Climara compare to other HRT products?

Climara offers a 7-day wear period and excellent adhesion, making it a convenient option compared to other transdermal systems and oral medications[1].

What are the market projections for Climara?

While specific projections for Climara are not detailed, the broader HRT market is expected to grow driven by increasing demand and technological advancements.

Sources

1. Clinical experience with a seven-day estradiol transdermal system - PubMed
2. NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025 - Drug Development
3. Clinical Trials Market Size, Trends & Go-To-Market Strategies - Towards Healthcare
4. Clinical Trials | Climara Pro® (estradiol/levonorgestrel transdermal system) - HCP.ClimaraPro
5. Pharmaceutical CRO Market Report 2025-2030 - GlobeNewswire