Clinical trial NCT00251082: Vasomotoric Symptoms Study of a 0.5 mg Estradiol and 2.5 mg Dydrogesterone Combination
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postmenopause
Keywords: hormone replacement
vasomotoric symptoms
bleeding pattern
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-11-09
Enrollment: 391
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility 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

Primary outcomes:
measure: The change in the number of moderate to severe hot flushes from baseline to week 13
timeFrame: 12 weeks
Secondary outcomes:
measure: 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;
timeFrame: 12 weeks
measure: Change in the Menopause Rating Scale from baseline to weeks 4 and 13;
timeFrame: 52 weeks
measure: Number of days with bleeding/spotting; Number of bleeding/spotting episodes; Number of days with a certain bleeding intensity (e.g. bleeding intensity =2);
timeFrame: 52 weeks
measure: Length of bleeding free intervals; Amenorrhoea yes/no (absence of spotting and bleeding); Absence of bleeding yes/no;
timeFrame: 52 weeks
measure: QualiPause Inventory 7D: weighted sum score of the symptoms
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: Site 11
city: Zagreb
country: Croatia
facility: Site 12
city: Zagreb
country: Croatia
facility: Site 13
city: Cannes
country: France
facility: Site 23
city: Cannes
country: France
facility: Site 24
city: Montpellier
country: France
facility: Site 21
city: Montpellier
country: France
facility: Site 22
city: Katowice
country: Poland
facility: Site 34
city: Kraków
country: Poland
facility: Site 33
city: Lódź
country: Poland
facility: Site 32
city: Warszawa
country: Poland
facility: Site 31
city: Bucharest
country: Romania
facility: Site 41
city: Bucharest
country: Romania
facility: Site 42
city: Bucharest
country: Romania
facility: Site 44
city: Craiova, Jud.Dolj
country: Romania
facility: Site 43
city: Moscow
country: Russian Federation
facility: Site 51
city: Moscow
country: Russian Federation
facility: Site 52
city: Moscow
country: Russian Federation
facility: Site 53
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References: