Overview

Hormone Replacement Therapy for Use in Postmenopausal Women for Relief of Hot Flushes and Urogenital Symptoms.

Status:
Completed
Trial end date:
2003-09-01
Target enrollment:
0
Participant gender:
Female
Summary
Multicenter, double-blind, controlled, parallel group, randomized study to compare the clinical benefit of Estradiol acetate tablets, estradiol tablets and conjugated equine estrogen tablets, each administered orally, once daily, to postmenopausal women.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Warner Chilcott
Treatments:
Estradiol
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol valerate
Estrogens
Estrogens, Conjugated (USP)
Polyestradiol phosphate
Criteria
Inclusion Criteria:

1. Age ≥ 40 years of age; bilateral oophorectomy ≥ 35 years of age.

2. Non-hysterectomized women:

- Amenorrhea for ≥ 12 months or

- Amenorrhea for ≤ 12 months, but longer than 6 months, and serum FSH (follicle
stimulating hormone) levels > 40 units/L and serum estradiol levels < 20 pg /mL,

Hysterectomized women:

- Bilateral oophorectomy - subjects may enter the study 6 weeks after surgery or

- History of removal of ovaries may be confirmed by - serum FSH levels > 40 units/L
and serum estradiol levels < 20 pg/mL or via surgical report / ultrasound.

3. Seven or more moderate or severe hot flushes daily for 1 week or 60 or more moderate
or severe flushes in 1 week during the 2 week screening period prior to study entry.

Exclusion Criteria:

1. Hormone therapy administered via the following routes and during the specified
timeframes: oral within 8 weeks, vaginal (rings, creams, gels) within 1 week,
transdermal within 4 weeks, intramuscular within 6 weeks, progestational implants,
estrogen or estrogen/progestational injectable drug therapy within 3 months, estrogen
pellet or progestational injectable within 6 months.

2. Abnormal Pap smear suggestive of low grade squamous intraepithelial lesion (LGSIL) or
worse. Enrollment of subjects with an ASCUS (atypical squamous cells of undetermined
significance) interpretation must be discussed with the sponsor prior to
randomization.

3. Urinary tract infection

4. Congestive heart failure

5. Uncontrolled hypertension; sitting systolic BP ≥ 160 mmHg or diastolic ≥ 95 mmHg

6. History of stroke or transient ischemic attacks

7. Treatment with anticoagulants (heparin or warfarin).

8. Uncontrolled thyroid disorders.

9. Insulin-dependent diabetes mellitus.

10. Increase frequency or severity of headaches including migraines during previous
estrogen therapy.