Vasomotoric Symptoms Study of a 0.5 mg Estradiol and 2.5 mg Dydrogesterone Combination

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00251082
• Date of registration: 08/11/2005
• Prospective Registration: Yes
• Primary sponsor: Solvay Pharmaceuticals
• Public title: Vasomotoric Symptoms Study of a 0.5 mg Estradiol and 2.5 mg Dydrogesterone Combination
• Scientific 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
• Date of first enrolment: December 2005
• Target sample size: 391
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00251082
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Croatia, France, Poland, Romania, Russian Federation

Contacts

• Name: Global Clinical Director Solvay
• Affiliation: Solvay Pharmaceuticals

Key inclusion & exclusion 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



Age minimum: 45 Years
Age maximum: 65 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Postmenopause

Intervention(s)

Drug: Placebo

Drug: continuous combined estradiol and dydrogesterone

Primary Outcome(s)

The change in the number of moderate to severe hot flushes from baseline to week 13 [Time Frame: 12 weeks]

Secondary Outcome(s)

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]

Change in the Menopause Rating Scale from baseline to weeks 4 and 13; [Time Frame: 52 weeks]

Length of bleeding free intervals; Amenorrhoea yes/no (absence of spotting and bleeding); Absence of bleeding yes/no; [Time Frame: 52 weeks]

QualiPause Inventory 7D: weighted sum score of the symptoms [Time Frame: 52 weeks]

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]

Secondary ID(s)

2004-00215-25

S102.3.119

Source(s) of Monetary Support

Please refer to primary and secondary sponsors