Endometrial Safety Study of a 0.5 mg Estradiol and 2.5 mg Dydrogesterone Combination
Information source: Solvay Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postmenopause
Intervention: 0.5 Mg Estradiol and 2.5 Mg Dydrogesterone (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Solvay Pharmaceuticals Official(s) and/or principal investigator(s):
Global Clinical Director Solvay, Study Director, Affiliation: Solvay Pharmaceuticals
Summary
The purpose of this study is to demonstrate endometrial safety of continuous combined 0. 5 mg
estradiol and 2. 5 mg dydrogesterone.
Clinical Details
Official title: Endometrial Safety of a Low Dose Continuous Combined 17 -Estradiol/Dydrogesterone Hormone Replacement Regimen (E2 0.5 mg/ D 2.5 mg) in Postmenopausal Women - A One-Year, Open Label, Multi-Center Study
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Primary outcome: Presence of endometrial hyperplasia or a more serious endometrial outcome during the 52 week treatment period
Secondary outcome: Number of days with bleeding/spotting; Number of bleeding/spotting episodes; Number of days with a certain bleeding intensity (e.g. bleeding intensity =2);Length of bleeding free intervals; Amenorrhoea yes/no (absence of spotting and bleeding); Absence of bleeding yes/no; QualiPause Inventory (domains: psychological, vasomotor, somatic, sexual, menstrual, androgenic): average score of the single items within the domain; QualiPause Inventory 7D: weighted sum score of the symptoms
Eligibility
Minimum age: 45 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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.
Locations and Contacts
Site 10, Zagreb, Croatia
Site 11, Zagreb, Croatia
Site 12, Zagreb, Croatia
Site 13, Zagreb, Croatia
Site 30, Kraków, Poland
Site 31, Miechów, Poland
Site 32, Katowice, Poland
Site 33, Warszawa, Poland
Site 34, Lublin, Poland
Site 35, Kraków, Poland
Site 36, Kraków, 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 20, Kiev, Ukraine
Site 21, Kiev, Ukraine
Site 22, Kiev, Ukraine
Site 23, Zaporozhye, Ukraine
Site 24, Donetsk, Ukraine
Additional Information
Starting date: April 2005
Ending date: December 2007
Last updated: March 11, 2008
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