Status:
COMPLETED
Vasomotoric Symptoms Study of a 0.5 mg Estradiol and 2.5 mg Dydrogesterone Combination
Lead Sponsor:
Solvay Pharmaceuticals
Conditions:
Postmenopause
Eligibility:
FEMALE
45-65 years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- Non-hysterectomised postmenopausal women
- Amenorrhoea for \>= 12 months
- Serum estradiol and follicle stimulating hormone (FSH) in the postmenopausal range
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
391 Patients enrolled
Trial Details
Trial ID
NCT00251082
Start Date
December 1 2005
End Date
October 1 2007
Last Update
March 12 2008
Active Locations (18)
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1
Site 11
Zagreb, Croatia
2
Site 12
Zagreb, Croatia
3
Site 13
Zagreb, Croatia
4
Site 23
Cannes, France