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.

Clinical Trial Conditions for CLIMARA

Condition Name

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

Condition MeSH

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