CompletedPhase 3

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

United States249 participantsStarted 2003-02

Plain-language 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.

Who can participate

Age range35 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age ≥ 40 years of age; bilateral oophorectomy ≥ 35 years of age.
✓. Non-hysterectomized women:
✓. 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

✕. 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.
✕. 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.
✕. Urinary tract infection
✕. Congestive heart failure
✕. Uncontrolled hypertension; sitting systolic BP ≥ 160 mmHg or diastolic ≥ 95 mmHg
✕. History of stroke or transient ischemic attacks
✕. Treatment with anticoagulants (heparin or warfarin).
✕. Uncontrolled thyroid disorders.

What they're measuring

Mean Change From Baseline in the Number of Moderate to Severe Hot Flushes, Week 4, ITT (Intention to Treat) Population

Timeframe: Baseline to Week 4

Mean Change From Baseline in the Number of Moderate to Severe Hot Flushes, Week 12, ITT Population

Timeframe: Baseline to Week 12

Trial details

NCT IDNCT01070979

SponsorWarner Chilcott

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2003-09

Results submitted2011-02-14

View on ClinicalTrials.gov More Hormone Replacement Therapy trials