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

This study has been terminated.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01015677
First received: November 17, 2009
Last updated: October 26, 2012
Last verified: October 2012
  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 2

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:


Further study details as provided by Merck Sharp & Dohme Corp.:

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 ]

Enrollment: 99
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  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 26, 2012
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 July 22, 2014