Comparison of Estrogen and Methyltestosterone Combination Treatments for Postmenopausal Hot Flushes

This study has been completed.
Sponsor:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00160342
First received: September 9, 2005
Last updated: August 14, 2008
Last verified: August 2008
  Purpose

This is a research study to evaluate the effectiveness, safety and side effects of several dose levels of esterified estrogens (EE) and methyltestosterone (MT) given individually and in combination compared to a placebo (a tablet with no active drug in it) as a possible treatment for vasomotor symptoms (such as hot flushes and flushing) of menopause. EE and testosterone are two hormones which are typically deficient in menopausal women


Condition Intervention Phase
Hot Flushes, Menopause, Postmenopause
Drug: Esterified Estrogens (EE) and Methyltestosterone (MT)
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 Multi-Center, Double-Blind, Placebo-Controlled Comparison of Multiple Doses of Esterified Estrogens and Methyltestosterone, in Combination and Alone, in Relieving Vasomotor Symptoms in Postmenopausal Women

Resource links provided by NLM:


Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:
  • Mean change in frequency of moderate to severe vasomotor symptoms (VMS) from baseline to Week 4 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Mean change in frequency of moderate to severe VMS from baseline to Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Mean change in severity of moderate to severe VMS from baseline to Week 4 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Mean change in severity of moderate to severe VMS from baseline to Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency and severity of moderate to severe and all hot flushes at each week [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Mean change from baseline to Week 12 in the moderate to severe vulvar and vaginal atrophy symptom identified by the subject as most bothersome [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Mean change from baseline to Week 12 in vaginal pH [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Mean change from baseline to Week 12 in vaginal maturation index (parabasal and superficial cells) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 1251
Study Start Date: June 2005
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: Esterified Estrogens (EE) and Methyltestosterone (MT)
oral tablet, QD, 12 weeks, 0.15 EE/0.15 MT
Experimental: 2 Drug: Esterified Estrogens (EE) and Methyltestosterone (MT)
oral tablet, QD, 12 weeks, 0.15 EE/0.15 MT
Experimental: 3 Drug: Esterified Estrogens (EE) and Methyltestosterone (MT)
oral tablet, QD, 12 weeks, 0.15 EE/0.30 MT
Active Comparator: 4 Drug: Esterified Estrogens (EE) and Methyltestosterone (MT)
oral tablet, QD, 12 weeks, 0.30 EE
Experimental: 5 Drug: Esterified Estrogens (EE) and Methyltestosterone (MT)
oral tablet, QD, 12 weeks, 0.30 EE/0.30 MT
Experimental: 6 Drug: Esterified Estrogens (EE) and Methyltestosterone (MT)
oral tablet, QD, 12 weeks, 0.30 EE/0.60 MT
Active Comparator: 7 Drug: Esterified Estrogens (EE) and Methyltestosterone (MT)
oral tablet, QD, 12 weeks, 0.45 EE
Active Comparator: 8 Drug: Esterified Estrogens (EE) and Methyltestosterone (MT)
oral tablet, QD, 12 weeks, 0.60 MT
Placebo Comparator: 9 Drug: Esterified Estrogens (EE) and Methyltestosterone (MT)
oral tablet, QD, 12 weeks, Placebo

  Eligibility

Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Be able to communicate with the Investigator and study staff and be able to complete the required study procedures,
  2. Be a female of any race between the ages of 45-65 years, in generally good health,
  3. Be either naturally or surgically postmenopausal (with or without a uterus)

Exclusion Criteria:

  1. Known sensitivity or contraindications to natural or synthetic estrogens, androgens or progestins,
  2. History of or current diagnosis of malignant melanoma, breast cancer or any cancer (except non-melanomatous skin cancer) diagnosed less than 5 years prior to beginning the study
  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: NCT00160342

  Show 125 Study Locations
Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
  More Information

No publications provided

Responsible Party: Sheri Rhodes, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00160342     History of Changes
Other Study ID Numbers: S030.2.112, 2005-002887-27
Study First Received: September 9, 2005
Last Updated: August 14, 2008
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Russia: Pharmacological Committee, Ministry of Health

Keywords provided by Solvay Pharmaceuticals:
Hormone replacement therapy, hot flushes, postmenopause

Additional relevant MeSH terms:
Flushing
Hot Flashes
Signs and Symptoms
Methyltestosterone
Testosterone 17 beta-cypionate
Testosterone
Testosterone enanthate
Testosterone undecanoate
Estrogens, Esterified (USP)
Estrone
Estrogens
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Anabolic Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Androgens

ClinicalTrials.gov processed this record on July 10, 2014