A Study of MK6913 for the Treatment of Hot Flashes in Postmenopausal Women (6913-004) - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT01015677

Purpose

This study will assess the safety, tolerability, and efficacy of MK6913 for the treatment of moderate-to-very-severe vasomotor symptoms (hot flashes or hot flushes) in postmenopausal women.

Condition	Intervention	Phase
Moderate to Severe Vasomotor Symptoms	Drug: MK6913 Drug: Comparator: 17beta-estradiol Drug: Comparator: placebo Drug: Comparator: MK6913	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Phase IIa, Randomized, Double-Blind, Placebo- and Active-Controlled Study to Examine MK6913 for the Treatment of Vasomotor Symptoms in Postmenopausal Women

Resource links provided by NLM:

Drug Information available for: Estradiol Estradiol 3-benzoate Polyestradiol phosphate Depogen Estradiol dipropionate Estradiol cypionate Estradiol valerate Estradiol acetate

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Change from baseline in the number of moderate to very severe hot flashes [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in hot flash severity score [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
Change from baseline in FSH (follicle-stimulating hormone) level [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	December 2009
Study Completion Date:	July 2010
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 MK6913 high dose	Drug: MK6913 Stage 1 and Stage 2: High-dose MK6913 once daily for 4 weeks.
Active Comparator: 2 17beta-estradiol	Drug: Comparator: 17beta-estradiol Stage 1 and Stage 2: 17beta-estradiol 1 mg daily for 4 weeks
Placebo Comparator: 3 placebo	Drug: Comparator: placebo Stage 1 and Stage 2: placebo only once daily for 4 weeks
Experimental: 4 MK6913 low dose	Drug: Comparator: MK6913 Stage 2 only: Low-dose MK6913 once daily for 4 weeks

Eligibility

Ages Eligible for Study:	35 Years to 60 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient is a woman with at least 50 moderate to very severe hot flash episodes per week
Patient is postmenopausal
Patient is between 45 and 60 years of age if naturally menopausal, or between 35 and 60 if she underwent a bilateral oophorectomy
Patient is not receiving hormone therapy
Patient has had both a normal mammogram and a normal Pap test in the past 6 months
Patient is generally healthy

Exclusion Criteria:

Patient has a history of cancer, except for certain skin cancers
Patient has undiagnosed vaginal bleeding or any uterine endometrial disorder
Patient currently uses tobacco products, or has used them in the last 6 months
Patient has HIV

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01015677

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Vice President of Late Stage Development, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT01015677 History of Changes
Other Study ID Numbers:	2009_691, MK6913-004
Study First Received:	November 17, 2009
Last Updated:	October 8, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Estradiol
Polyestradiol phosphate
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estrogens
Hormones

Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on February 09, 2012