| September 9, 2005 |
| March 11, 2008 |
| April 2005 |
| December 2007 (final data collection date for primary outcome measure) |
| Presence of endometrial hyperplasia or a more serious endometrial outcome during the 52 week treatment period [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ] |
| Same as current |
| Complete list of historical versions of study NCT00160316 on ClinicalTrials.gov Archive Site |
- Number of days with bleeding/spotting; Number of bleeding/spotting episodes; Number of days with a certain bleeding intensity (e.g. bleeding intensity =2); [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
- Length of bleeding free intervals; Amenorrhoea yes/no (absence of spotting and bleeding); Absence of bleeding yes/no; [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
- 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 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
|
| Same as current |
| |
| Endometrial Safety Study of a 0.5 mg Estradiol and 2.5 mg Dydrogesterone Combination |
| 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 |
The purpose of this study is to demonstrate endometrial safety of continuous combined 0.5 mg estradiol and 2.5 mg dydrogesterone. |
| |
| Phase III |
| Interventional |
| Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
| Postmenopause |
| Drug: 0.5 Mg Estradiol and 2.5 Mg Dydrogesterone |
| |
| |
| |
| Completed |
| 454 |
| December 2007 |
| December 2007 (final data collection date for primary outcome measure) |
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.
|
| Female |
| 45 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Croatia, Poland, Romania, Ukraine |
| |
| NCT00160316 |
| Gregor Eibes, Solvay Pharmaceuticals |
| S102.3.117, 2004-000227-15 |
| Solvay Pharmaceuticals |
|
| Study Director: |
Global Clinical Director Solvay |
Solvay Pharmaceuticals |
|
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| Solvay Pharmaceuticals |
| March 2008 |