Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01015677
Other study ID # 6913-004
Secondary ID MK-6913-004
Status Terminated
Phase Phase 2
First received
Last updated
Start date December 17, 2009
Est. completion date July 30, 2010

Study information

Verified date August 2018
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will assess the safety, tolerability, and efficacy of MK-6913 for the treatment of moderate-to-very-severe vasomotor symptoms (hot flashes or hot flushes) in postmenopausal women. The primary study hypothesis is that one or more doses of MK-6913 will result in a significantly greater reduction from baseline, compared to placebo, in the number of moderate to very severe hot flashes after 4 weeks of treatment.


Recruitment information / eligibility

Status Terminated
Enrollment 99
Est. completion date July 30, 2010
Est. primary completion date July 30, 2010
Accepts healthy volunteers No
Gender Female
Age group 35 Years to 60 Years
Eligibility Inclusion Criteria:

- Woman with at least 50 moderate to very severe hot flash episodes per week

- Postmenopausal

- Between 45 and 60 years of age if naturally menopausal, or between 35 and 60 if she underwent a bilateral oophorectomy

- Not receiving hormone therapy

- Has had both a normal mammogram and a normal Pap test in the past 6 months

- Generally healthy

Exclusion Criteria:

- A history of cancer, except for certain skin cancers

- Undiagnosed vaginal bleeding or any uterine endometrial disorder

- Currently uses tobacco products, or has used them in the last 6 months

- Has human immunodeficiency virus (HIV)

Study Design


Related Conditions & MeSH terms

  • Moderate to Severe Vasomotor Symptoms in Postmenopausal
  • Women

Intervention

Drug:
MK-6913

17-ß estradiol

Placebo to MK-6913

Placebo to 17-ß estradiol

MK-6913 25 mg


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type Measure Description Time frame Safety issue
Primary Percent Change From Baseline in the Number of Weekly Moderate to Very Severe Hot Flashes (Excluding Outliers) at Week 4 Hot flashes were recorded in real time and hot flashes recorded retrospectively in the morning and evening reports in a diary day via the Hot Flash e-diary were summed to determine the total number of hot flashes over a diary day. The total number of weekly moderate or worse hot flashes were calculated as the sum of the total number of hot flashes that occur over a diary week (non-missing diary day), divided by the number of days of diary completion, and multiplied by 7 (standardized week). At least 4 non-missing diary days were required to define the total number of weekly moderate or worse hot flashes. Hot flash data was excluded for participants whose number of moderate to severe hot flashes per week were in the top 1% of number of hot flashes reported to exclude any outlier effect. Baseline and Week 4
Primary Number of Participants Who Experienced at Least One or More Adverse Events (AE) An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Up to 6 weeks
Primary Number of Participants Who Discontinued Study Drug Due to an AE An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Up to 4 weeks
Secondary Percent Change From Baseline in the Weekly Hot Flash Severity Score (Combining Severe and Very Severe Score) at Week 4 Hot flash severity score is calculated by the sum of: the number of mild hot flashes, 2 times number of moderate hot flashes, 3 times the number of severe hot flashes, and 4 times the number of very severe hot flashes. This sum was standardized to a 7-day week if there were any missing days in the e-diary. The severity of each hot flash was recorded by the Hot Flash e-diary. Baseline and Week 4
Secondary Change From Baseline in Follicle-stimulating Hormone (FSH) Level at Week 4 FSH was measured to assess estrogen receptor (ER) selectivity (a biomarker for ERa activity and a pharmacodynamic endpoint). Baseline and Week 4
See also
  Status Clinical Trial Phase
Completed NCT02700698 - Mitochondrial Function in Circulating Cells and Muscle Tissue
Recruiting NCT04532801 - Evaluation of Kisspeptin Glucose-Stimulated Insulin Secretion With Physiologic Mixed Meal Tolerance Phase 1
Completed NCT04880525 - The Effect of a Weight-Loss Diet in Women Doing Reformer Pilates: A 12-Week Evaluation N/A
Completed NCT03810716 - Promotion of Family Planning Methods Through an Interactive Platform Offered in Growth and Development Control Services N/A
Completed NCT05882409 - Education Given on Their Attitudes Towards Violence Against Women and Their Conflict N/A
Completed NCT05473026 - Grateful Strides Toward Physical Activity and Well-Being for Black Breast Cancer Survivors N/A
Active, not recruiting NCT05057546 - Ovarian Hormone Regulation of Central and Cerebrovascular Hemodynamics (NoMEN Study) Phase 4
Completed NCT02951949 - Estrogen Exposure and Atherosclerosis in Postmenopausal Women
Completed NCT01251887 - Dietary Essential Fatty Acid Regulation of Omega-3 HUFA Metabolism; Satiety and Body Composition N/A
Completed NCT01029210 - Temporomandibular Disorders and Osteoporosis N/A
Completed NCT05817773 - The Design, Development and Effect of Breastfeeding Cradle on Breastfeeding Self-efficacy N/A
Completed NCT04044638 - Eight Week Strength Training Reduces Blood Pressure of Middle Age Women N/A
Completed NCT05100914 - Evaluation of the Effects of the Couple-based Family Nursing for Women With Breast Cancer N/A
Completed NCT05657600 - Effectiveness of Video-based Yoga Practices for Sedentary Women in Pandemic Days
Not yet recruiting NCT06295510 - Observational Study of the Association Between Food Intake and Endometrial Polyps
Completed NCT03812211 - Evaluation of a Supplement for Weight Management in Obese and Overweight Individuals N/A
Recruiting NCT06468891 - Analyzing Gait Parameters Among Women With and Without Stress Urinary Incontinence
Not yet recruiting NCT05875545 - Effects of Breathing Exercises in Women With Chronic Pelvic Pain N/A
Completed NCT03893084 - Women's Health Behaviors Stages of Change (Transtheoretical Model) in Preconception Period: A Randomized Control Study N/A
Completed NCT04496869 - Psychological Impact of COVID19 Among Women Undergoing Infertility Treatment