Know Cancer

or
forgot password

Endometrial Safety of a Low Dose Continuous Combined 17 -Estradiol/Dydrogesterone Hormone Replacement Regimen (E2 0.5 mg/ D 2.5 mg) in Postmenopausal Women - A One-Year, Open Label, Multi-Center Study


Phase 3
45 Years
N/A
Not Enrolling
Female
Postmenopause

Thank you

Trial Information

Endometrial Safety of a Low Dose Continuous Combined 17 -Estradiol/Dydrogesterone Hormone Replacement Regimen (E2 0.5 mg/ D 2.5 mg) in Postmenopausal Women - A One-Year, Open Label, Multi-Center Study


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Presence of endometrial hyperplasia or a more serious endometrial outcome during the 52 week treatment period

Outcome Time Frame:

52 weeks

Safety Issue:

Yes

Principal Investigator

Global Clinical Director Solvay

Investigator Role:

Study Director

Investigator Affiliation:

Solvay Pharmaceuticals

Authority:

Romania: State Institute for Drug Control

Study ID:

S102.3.117

NCT ID:

NCT00160316

Start Date:

April 2005

Completion Date:

December 2007

Related Keywords:

  • Postmenopause
  • Adenoma

Name

Location