| November 8, 2005 |
| March 11, 2008 |
| December 2005 |
| October 2007 (final data collection date for primary outcome measure) |
| The change in the number of moderate to severe hot flushes from baseline to week 13 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00251082 on ClinicalTrials.gov Archive Site |
- Change in the number of hot flushes from baseline to week 13; Change in the number of hot flushes and moderate to severe hot flushes from baseline to weeks 4 and 8; [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Change in the Menopause Rating Scale from baseline to weeks 4 and 13; [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
- 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: No ]
- 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: No ]
- QualiPause Inventory 7D: weighted sum score of the symptoms [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
|
| Same as current |
| |
| Vasomotoric Symptoms Study of a 0.5 mg Estradiol and 2.5 mg Dydrogesterone Combination |
| A Randomized, Placebo-Controlled, Double-Blind, Multi-National Study to Demonstrate Efficacy of Continuous Combined 0.5 mg Estradiol and 2.5 mg Dydrogesterone in the Treatment of Vasomotor Symptoms in Postmenopausal Women in Comparison to Placebo Over 3 Months, and to Investigate the Bleeding Pattern Over a Double-Blind Treatment Period of One Year Compared With Continuous Combined 1 mg Estradiol and 5 mg Dydrogesterone |
To demonstrate efficacy of continuous combined 0.5 mg estradiol and 2.5 mg dydrogesterone versus placebo in the treatment of vasomotor symptoms after a treatment period of 3 months and to investigate the bleeding pattern over a treatment period of one year |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Postmenopause |
- Drug: continuous combined estradiol and dydrogesterone
- Drug: Placebo
|
| |
| |
| |
| Completed |
| 391 |
| October 2007 |
| October 2007 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Non-hysterectomised postmenopausal women
- Amenorrhoea for >= 12 months
- Serum estradiol and follicle stimulating hormone (FSH) in the postmenopausal range
Exclusion Criteria:
- Known hypersensitivity to estradiol, dydrogesterone or any of the excipients of the study medication
- Baseline endometrial biopsy result other than described in the inclusion criteria (no endometrial tissue for diagnosis, hyperplasia, carcinoma).
- 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
|
| Female |
| 45 Years to 65 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Croatia, France, Poland, Romania, Russian Federation |
| |
| NCT00251082 |
| Gregor Eibes, Solvay Pharmaceuticals |
| S102.3.119, 2004-00215-25 |
| Solvay Pharmaceuticals |
|
| Study Director: |
Global Clinical Director Solvay |
Solvay Pharmaceuticals |
|
|
| Solvay Pharmaceuticals |
| March 2008 |
