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Completed

NCT Number: NCT00160342

Comparison of Estrogen and Methyltestosterone Combination Treatments for Postmenopausal Hot Flushes

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

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Key information

Conditions

Hot Flushes, Menopause, Postmenopause Hot Flashes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

45 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Site 120, Abbotsford British Columbia, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Known sensitivity or contraindications to natural or synthetic estrogens, androgens or progestins,
  • 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

Treatment and study plan

Esterified Estrogens (EE) and Methyltestosterone (MT)

Drug

oral tablet, QD, 12 weeks, 0.15 EE/0.15 MT

Primary outcomes

  1. Mean change in frequency of moderate to severe vasomotor symptoms (VMS) from baseline to Week 4

    Time frame: 4 weeks

  2. Mean change in frequency of moderate to severe VMS from baseline to Week 12

    Time frame: 12 weeks

  3. Mean change in severity of moderate to severe VMS from baseline to Week 4

    Time frame: 4 weeks

  4. Mean change in severity of moderate to severe VMS from baseline to Week 12

    Time frame: 12 weeks

Secondary outcomes

  1. Frequency and severity of moderate to severe and all hot flushes at each week

    Time frame: 12 weeks

  2. 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

  3. Mean change from baseline to Week 12 in vaginal pH

    Time frame: 12 weeks

  4. Mean change from baseline to Week 12 in vaginal maturation index (parabasal and superficial cells)

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Solvay Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Sep 12, 2005
Registry last updated
Aug 15, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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