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

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Solvay Pharmaceuticals
• Treatments: Dydrogesterone; Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Polyestradiol phosphate

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