Status:
COMPLETED
Endometrial Safety Study of a 0.5 mg Estradiol and 2.5 mg Dydrogesterone Combination
Lead Sponsor:
Solvay Pharmaceuticals
Conditions:
Postmenopause
Eligibility:
FEMALE
45+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to demonstrate endometrial safety of continuous combined 0.5 mg estradiol and 2.5 mg dydrogesterone.
Eligibility Criteria
Inclusion
- Amenorrhoea for \>= 12 months.
- 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
- Previous systemic unopposed estrogen replacement therapy over 6 months or more.
- 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.
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
454 Patients enrolled
Trial Details
Trial ID
NCT00160316
Start Date
April 1 2005
End Date
December 1 2007
Last Update
March 12 2008
Active Locations (22)
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1
Site 10
Zagreb, Croatia
2
Site 11
Zagreb, Croatia
3
Site 12
Zagreb, Croatia
4
Site 13
Zagreb, Croatia