Vasomotoric Symptoms Study of a 0.5 mg Estradiol and 2.5 mg Dydrogesterone Combination
NCT ID: NCT00251082
Last Updated: 2008-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
391 participants
INTERVENTIONAL
2005-12-31
2007-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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A
continuous combined estradiol and dydrogesterone
0.5 Mg Estradiol and 2.5 Mg Dydrogesterone
B
continuous combined estradiol and dydrogesterone
1 Mg Estradiol and 5 Mg Dydrogesterone
C
Placebo
Placebo
Interventions
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continuous combined estradiol and dydrogesterone
0.5 Mg Estradiol and 2.5 Mg Dydrogesterone
continuous combined estradiol and dydrogesterone
1 Mg Estradiol and 5 Mg Dydrogesterone
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* Amenorrhoea for \>= 12 months
* Serum estradiol and follicle stimulating hormone (FSH) in the postmenopausal range
* Insufficient endometrial tissue for diagnosis obtained at baseline biopsy and endometrial thickness \>= 5 mm (double layer) by transvaginal ultrasound.
* The presence of an endometrial polyp at baseline.
* Abnormal (un-investigated and/or unexplained) vaginal bleeding in the last 12 months prior to Screening Visit (Visit 1).
* Estradiol pellet/implant therapy during the past 6 months.
* Previous systemic unopposed estrogen replacement therapy over 6 months or more.
* History or presence of malignant neoplasms other than basal or spinal cell carcinoma of the skin
Exclusion Criteria
45 Years
65 Years
FEMALE
No
Sponsors
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Solvay Pharmaceuticals
INDUSTRY
Responsible Party
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Solvay Pharmaceuticals
Principal Investigators
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Global Clinical Director Solvay
Role: STUDY_DIRECTOR
Solvay Pharmaceuticals
Locations
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Site 11
Zagreb, , Croatia
Site 12
Zagreb, , Croatia
Site 13
Zagreb, , Croatia
Site 23
Cannes, , France
Site 24
Cannes, , France
Site 21
Montpellier, , France
Site 22
Montpellier, , France
Site 34
Katowice, , Poland
Site 33
Krakow, , Poland
Site 32
Lódź, , Poland
Site 31
Warsaw, , Poland
Site 41
Bucharest, , Romania
Site 42
Bucharest, , Romania
Site 44
Bucharest, , Romania
Site 43
Craiova, Jud.Dolj, , Romania
Site 51
Moscow, , Russia
Site 52
Moscow, , Russia
Site 53
Moscow, , Russia
Countries
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Other Identifiers
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2004-00215-25
Identifier Type: -
Identifier Source: secondary_id
S102.3.119
Identifier Type: -
Identifier Source: org_study_id
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