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

Solvay

Status and phase

Completed

Phase 3

Conditions

Postmenopause

Treatments

Drug: Placebo

Drug: continuous combined estradiol and dydrogesterone

Study type

Interventional

Funder types

Industry

Identifiers

NCT00251082

S102.3.119

2004-00215-25

Details and patient eligibility

About

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

Enrollment

391 patients

Sex

Female

Ages

45 to 65 years old

Volunteers

No Healthy Volunteers

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