Endometrial Safety Study of a 0.5 mg Estradiol and 2.5 mg Dydrogesterone Combination
NCT ID: NCT00160316
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
454 participants
INTERVENTIONAL
2005-04-30
2007-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
0.5 Mg Estradiol and 2.5 Mg Dydrogesterone
p.o. daily
Interventions
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0.5 Mg Estradiol and 2.5 Mg Dydrogesterone
p.o. daily
Eligibility Criteria
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Inclusion Criteria
* Serum estradiol and FSH level within the postmenopausal range
* Baseline endometrial biopsy assessed by light microscopic histological evaluation revealing: insufficient endometrial tissue for diagnosis because of insufficient available (atrophic) endometrial tissue (not because of an inaccessible cervix) and endometrial thickness \< 5 mm (double layer) by transvaginal ultrasound, atrophic endometrium, secretory endometrium, menstrual type endometrium, proliferative endometrium
Exclusion Criteria
* Any estrogen, progestogen, and/or androgen therapy in the last four weeks before Screening Visit (Visit 1). The baseline endometrial biopsy should in all cases be taken after cessation of the withdrawal bleeding due to previous hormone replacement therapy.
* History or presence of an estrogen dependent neoplasia (including breast- cancer).
* History or presence of malignant neoplasms other than basal or spinal cell carcinoma of the skin.
45 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 10
Zagreb, , Croatia
Site 11
Zagreb, , Croatia
Site 12
Zagreb, , Croatia
Site 13
Zagreb, , Croatia
Site 32
Katowice, , Poland
Site 30
Krakow, , Poland
Site 35
Krakow, , Poland
Site 36
Krakow, , Poland
Site 34
Lublin, , Poland
Site 31
Miechów, , Poland
Site 33
Warsaw, , Poland
Site 40
Bucharest, , Romania
Site 41
Bucharest, , Romania
Site 42
Bucharest, , Romania
Site 43
Bucharest, , Romania
Site 44
Bucharest, , Romania
Site 45
Bucharest, , Romania
Site 24
Donetsk, , Ukraine
Site 20
Kiev, , Ukraine
Site 21
Kiev, , Ukraine
Site 22
Kiev, , Ukraine
Site 23
Zaporizhzhya, , Ukraine
Countries
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Other Identifiers
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2004-000227-15
Identifier Type: -
Identifier Source: secondary_id
S102.3.117
Identifier Type: -
Identifier Source: org_study_id
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