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

S

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)

454 participants in 1 patient group

1
Experimental group
Treatment:
Drug: 0.5 Mg Estradiol and 2.5 Mg Dydrogesterone

Trial contacts and locations

22

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Data sourced from clinicaltrials.gov

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