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Vasomotoric Symptoms Study of a 0.5 mg Estradiol and 2.5 mg Dydrogesterone Combination

NCT00251082 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 391

Last updated 2008-03-12

No results posted yet for this study

Summary

To demonstrate efficacy of continuous combined 0.5 mg estradiol and 2.5 mg dydrogesterone versus placebo in the treatment of vasomotor symptoms after a treatment period of 3 months and to investigate the bleeding pattern over a treatment period of one year

Conditions

  • Postmenopause

Interventions

DRUG

continuous combined estradiol and dydrogesterone

0.5 Mg Estradiol and 2.5 Mg Dydrogesterone

DRUG

continuous combined estradiol and dydrogesterone

1 Mg Estradiol and 5 Mg Dydrogesterone

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Solvay Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Global Clinical Director Solvay · Solvay Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2007-10-31
Completion
2007-10-31

Countries

  • Croatia
  • France
  • Poland
  • Romania
  • Russia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00251082 on ClinicalTrials.gov