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

NCT02019589 | Terminated Phase 3

• 1 other identifier: TXP13-01
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 22

Brief Summary

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.)

Conditions

Secondary Amenorrhea

Keywords

Secondary Amenorrhea; SPRY Trial

Outcome Measures

Primary Outcomes (1)

• • The proportion of subjects at Cycle 3 Day 24 ± 1 day on active treatment compared to placebo with complete secretory activity on endometrial biopsy.

  3 Cycles

Secondary Outcomes (1)

• • The proportion of subjects at Cycle 3 Day 24 ± 1 day on active treatment compared to placebo with total secretory activity (defined as the aggregate of partial and complete secretory activity) on endometrial biopsy.

  3 cycles

Study Arms (3)

Progesterone 225 mg/day

ACTIVE COMPARATOR

Progesterone + Placebo

Drug: Progesterone; Drug: Placebo

Progesterone, 300 mg/ day

ACTIVE COMPARATOR

Progesterone + Placebo

Drug: Progesterone; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Progesterone DRUG

Progesterone 225 mg/day; Progesterone, 300 mg/ day

Placebo DRUG

Placebo; Progesterone 225 mg/day; Progesterone, 300 mg/ day

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.)
• 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).

Sponsors & Collaborators

• TherapeuticsMD: lead

Study Sites (22)

Precision Trials/New Horizons Women's Care

Chandler, Arizona, 85224, United States

Location

Precision Clinical Trials/Arizona Wellness Center for Women

Phoenix, Arizona, 85032, United States

Location

Visions Clinical Research

Tucson, Arizona, 85712, United States

Location

California Family Health Council

Berkeley, California, 94710, United States

Location

California Family Health Council

Los Angeles, California, 90010, United States

Location

Clinical Research Consulting

Milford, Connecticut, 06460, United States

Location

Nature Coast Clinical Research

Crystal River, Florida, 34429, United States

Location

Comprehensive Clinical Trials, LLC

West Palm Beach, Florida, 33409, United States

Location

Cypress Medical Research Center

Wichita, Kansas, 67226, United States

Location

Women's Clinic of Lincoln, P.C.

Lincoln, Nebraska, 68510, United States

Location

Lawrence OB-Gyn Clinical Research

Lawrenceville, New Jersey, 08648, United States

Location

Suffolk OBGYN

Port Jefferson, New York, 11777, United States

Location

Wake Research Associates

Raleigh, North Carolina, 27615, United States

Location

Lyndhurst Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

University of Cincinnati Physicians Company

Cincinnati, Ohio, 45229, United States

Location

HWC Women's Research Center

Englewood, Ohio, 45322, United States

Location

Vista Clinical Research

Columbia, South Carolina, 29201, United States

Location

Chattanooga Medical Research

Chattanooga, Tennessee, 37404, United States

Location

Methodist Charlton Medical Center

DeSoto, Texas, 75115, United States

Location

The Woman's Hospital of Texas Clinical Research Center

Houston, Texas, 77054, United States

Location

PRO/Salt Lake Women's Center

Sandy City, Utah, 84070, United States

Location

Tidewater Clinical Research

Virginia Beach, Virginia, 23456, United States

Location

MeSH Terms

Interventions

Progesterone

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2013
• First Posted: December 24, 2013
• Study Start: January 20, 2014
• Primary Completion: October 31, 2014
• Study Completion: October 31, 2014
• Last Updated: May 8, 2018

Record last verified: 2018-05

Locations

US (22)