Vasomotoric Symptoms 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: continuous combined estradiol and dydrogesterone (Drug); continuous combined estradiol and dydrogesterone (Drug); Placebo (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
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
Clinical Details
Official title: 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
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: The change in the number of moderate to severe hot flushes from baseline to week 13
Secondary outcome: 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;Change in the Menopause Rating Scale from baseline to weeks 4 and 13; 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 7D: weighted sum score of the symptoms
Eligibility
Minimum age: 45 Years.
Maximum age: 65 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Site 11, Zagreb, Croatia
Site 12, Zagreb, Croatia
Site 13, Zagreb, Croatia
Site 21, Montpellier, France
Site 22, Montpellier, France
Site 23, Cannes, France
Site 24, Cannes, France
Site 31, Warszawa, Poland
Site 32, Lódź, Poland
Site 33, Kraków, Poland
Site 34, Katowice, Poland
Site 41, Bucharest, Romania
Site 42, Bucharest, Romania
Site 43, Craiova, Jud.Dolj, Romania
Site 44, Bucharest, Romania
Site 51, Moscow, Russian Federation
Site 52, Moscow, Russian Federation
Site 53, Moscow, Russian Federation
Additional Information
Starting date: December 2005
Ending date: October 2007
Last updated: March 11, 2008
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