A Phase 3, Randomized, Three-Cycle, Double-Blind, Placebo-Controlled Study to Evaluate Induction of Secretory Conversion of Endometrium and Withdrawal Bleeding for Secondary Amenorrhea

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Secondary Amenorrhea

In brief

This study will be a Phase 3, randomized, three-cycle, double-blind, placebo-controlled, parallel group, multiple-dose design. The study design has four phases: Screening Period; Open-Label Estrogen-Priming Period (Run-In Period); Blinded Treatment Period; and Follow-Up. The Open Label Priming Period and Blinded Treatment Period cover a total of three 28-day cycles. Clinical evaluations will be performed at the following time points: Screening Period: • Screening Period (approximately 42 Days) Open-Label Estrogen Priming Period (Run In Period): * Visit 1 Baseline (Cycle 1, Day 1) * Telephone Interview (Cycle 1, Day 28 \[- 3 d to ±1d\]) Blinded Treatment Period: * Visit 2 Randomization (Cycle 2, Day 12 \[±2d\]) * Visit 3 Interim (Cycle 3, Day 12 \[±2d\]) * Visit 4 End of treatment (Cycle 3, Day 24 \[±1d\]) Follow-Up Period: * Visit 5 Follow-Up (Approximately 10 days after the last treatment) * Telephone Interview (Approximately 2-4 weeks after completion of progestin course) (Only applies to subjects receiving an approved progestin therapy for proliferative endometrium, as determined by biopsy.)

Key facts

Study ID

NCT02019589

Run by

TherapeuticsMD

People needed

6

Starts

2014-01-20

Expected to finish

2014-10-31

Last updated by the study team

2018-05-08

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Be female, premenopausal, 18 to 40 years of age (inclusive, at the time of randomization)
• Have secondary amenorrhea, defined as the absence of menstruation for at least 90 days prior to Visit 1 (Cycle 1, Day 1).
• Have an intact uterus.
• Be otherwise healthy, as judged by the Investigator physician, based on a medical evaluation performed during the screening period prior to the initial dose of Estrace®. The medical evaluation must include:
• a normal or non-clinically significant physical examination, including vital signs (sitting blood pressure, heart rate, respiratory rate and temperature). Acceptable sitting systolic blood pressure is <140 mmHg and diastolic blood pressure is <90 mmHg at screening. A subject may be taking up to two antihypertensive medications.
• a normal or non-clinically significant pelvic examination performed during screening.
• a normal or non-clinically significant clinical breast examination performed during screening. An acceptable breast examination is defined as no masses, adenopathy, or other findings identified that are suspicious of malignancy.
• a normal or non-clinically significant 12-lead ECG as determined by the Principal Investigator (PI) or medical Sub-Investigator.
• Have a negative serum pregnancy test at Screening, and be willing to use an acceptable form of non-hormonal birth control (e.g., barrier method with spermicide) during the study. (The "rhythm method," withdrawal, or an IUD are NOT acceptable methods.)
• Exclusionary:
• Be postmenopausal.
• Be diagnosed with primary amenorrhea.
• Have had bilateral oophorectomy and/or hysterectomy.
• Have a history of thrombosis of deep veins or arteries or a thromboembolic disorder.
• Have a history of coronary artery or cerebrovascular disease (e.g., myocardial infarction, stroke, TIA).
• Have a history of liver or kidney dysfunction/disorder (e.g., hepatitis C or chronic renal failure).
• Have a history of gallbladder dysfunction/disorders (e.g., cholangitis, cholecystitis), unless gallbladder has been removed.
• Have a history of diabetes, thyroid disease or any other endocrine disease. (Subjects with diet-controlled diabetes or controlled hypothyroid disease at screening are not excluded.)
• Have a history of undiagnosed vaginal bleeding.
• Have any history of endometrial hyperplasia, uterine/endometrial, breast or ovarian cancer.
• Have any history of malignancy within the last 5 years, with the exception of basal cell (excluded if within one year) or squamous cell (excluded if within one year) carcinoma of the skin.
• Have a history of any other cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychological, or musculoskeletal disease or disorder that is clinically significant in the opinion of the Principal Investigator or medical Sub-Investigator.
• Have used injectable or implantable estrogen, progestin/progesterone, testosterone or androgens within the last 6 months prior to Visit 1 or plan to use them during the study.
• Have used any of the following hormonal products within the last 90 days prior to Visit 1 or plan to use them during the study:
• Vaginal nonsystemic hormonal products (rings, creams, gels) or vaginal systemic hormonal products (e.g., FemRing).

Where it is running

• Precision Trials/New Horizons Women's Care — Chandler, Arizona, United States
• Precision Clinical Trials/Arizona Wellness Center for Women — Phoenix, Arizona, United States
• Visions Clinical Research — Tucson, Arizona, United States
• California Family Health Council — Berkeley, California, United States
• California Family Health Council — Los Angeles, California, United States
• Clinical Research Consulting — Milford, Connecticut, United States
• Nature Coast Clinical Research — Crystal River, Florida, United States
• Comprehensive Clinical Trials, LLC — West Palm Beach, Florida, United States
• Cypress Medical Research Center — Wichita, Kansas, United States
• Women's Clinic of Lincoln, P.C. — Lincoln, Nebraska, United States
• Lawrence OB-Gyn Clinical Research — Lawrenceville, New Jersey, United States
• Suffolk OBGYN — Port Jefferson, New York, United States
• Wake Research Associates — Raleigh, North Carolina, United States
• Lyndhurst Clinical Research — Winston-Salem, North Carolina, United States
• University of Cincinnati Physicians Company — Cincinnati, Ohio, United States
• HWC Women's Research Center — Englewood, Ohio, United States
• Vista Clinical Research — Columbia, South Carolina, United States
• Chattanooga Medical Research — Chattanooga, Tennessee, United States
• Methodist Charlton Medical Center — DeSoto, Texas, United States
• The Woman's Hospital of Texas Clinical Research Center — Houston, Texas, United States
• PRO/Salt Lake Women's Center — Sandy City, Utah, United States
• Tidewater Clinical Research — Virginia Beach, Virginia, United States

Full record on ClinicalTrials.gov

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