Endometrial Safety Study of a 0.5 mg Estradiol and 2.5 mg Dydrogesterone Combination

Solvay

Status and phase: Completed; Phase 3

Conditions: Postmenopause

Treatments: Drug: 0.5 Mg Estradiol and 2.5 Mg Dydrogesterone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00160316

S102.3.117

2004-000227-15

Details and patient eligibility

About

The purpose of this study is to demonstrate endometrial safety of continuous combined 0.5 mg estradiol and 2.5 mg dydrogesterone.

Enrollment: 454 patients

Sex: Female

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Amenorrhoea for >= 12 months.
• Serum estradiol and FSH level within the postmenopausal range
• Baseline endometrial biopsy assessed by light microscopic histological evaluation revealing: insufficient endometrial tissue for diagnosis because of insufficient available (atrophic) endometrial tissue (not because of an inaccessible cervix) and endometrial thickness < 5 mm (double layer) by transvaginal ultrasound, atrophic endometrium, secretory endometrium, menstrual type endometrium, proliferative endometrium

Exclusion criteria

• Previous systemic unopposed estrogen replacement therapy over 6 months or more.
• Any estrogen, progestogen, and/or androgen therapy in the last four weeks before Screening Visit (Visit 1). The baseline endometrial biopsy should in all cases be taken after cessation of the withdrawal bleeding due to previous hormone replacement therapy.
• History or presence of an estrogen dependent neoplasia (including breast- cancer).
• History or presence of malignant neoplasms other than basal or spinal cell carcinoma of the skin.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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454 participants in 1 patient group

1

Experimental group

Treatment:

Drug: 0.5 Mg Estradiol and 2.5 Mg Dydrogesterone