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

Completed · Phase 3

Conditions studied: Hormone Replacement Therapy

In brief

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.

Key facts

Study ID

NCT01070979

Run by

Warner Chilcott

People needed

249

Starts

2003-02-01

Expected to finish

2003-09-01

Last updated by the study team

2013-04-22

Who can join

Age: 35 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.
• Insulin-dependent diabetes mellitus.
• Increase frequency or severity of headaches including migraines during previous estrogen therapy.

Where it is running

• Warner Chilcott Investigational Site — Phoenix, Arizona, United States
• Warner Chilcott Investigational Site — Carmichael, California, United States
• Warner Chilcott Investigational Site — San Diego, California, United States
• Warner Chilcott Investigational Site — San Diego, California, United States
• Warner Chilcott Investigational Site — Aventura, Florida, United States
• Warner Chilcott Investigational Site — Boynton Beach, Florida, United States
• Warner Chilcott Investigational Site — Clearwater, Florida, United States
• Warner Chilcott Investigational Site — Daytona Beach, Florida, United States
• Warner Chilcott Investigational Site — Gainesville, Florida, United States
• Warner Chilcott Investigational Site — Longwood, Florida, United States
• Warner Chilcott Investigational Site — Melbourne, Florida, United States
• Warner Chilcott Investigational Site — Miami, Florida, United States
• Warner Chilcott Investigational Site — Palm Springs, Florida, United States
• Warner Chilcott Investigational Site — Pinellas Park, Florida, United States
• Warner Chilcott Investigational Site — Sarasota, Florida, United States
• Warner Chilcott Investigational Site — Venice, Florida, United States
• Warner Chilcott Investigational Site — Roswell, Georgia, United States
• Warner Chilcott Investigational Site — Chicago, Illinois, United States
• Warner Chilcott Investigational Site — Peoria, Illinois, United States
• Warner Chilcott Investigational Site — Laurel, Maryland, United States
• Warner Chilcott Investigational Site — Lincoln, Nebraska, United States
• Warner Chilcott Investigational Site — Raleigh, North Carolina, United States
• Warner Chilcott Investigational Site — Winston-Salem, North Carolina, United States
• Warner Chilcott Investigational Site — Cleveland, Ohio, United States
• Warner Chilcott Investigational Site — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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