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
Public ClinicalTrials.gov record NCT02019589. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Randomized, Three-Cycle, Double-Blind, Placebo-Controlled Study to Evaluate Induction of Secretory Conversion of Endometrium and Withdrawal Bleeding After Administration of TX-12-002-HR in Estrogen-Primed Women With Secondary Amenorrhea
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.)
Study identification
- NCT ID
- NCT02019589
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 6 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 40 Years
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 20, 2014 (Actual)
- Primary completion
- Oct 31, 2014 (Actual)
- Completion
- Oct 31, 2014 (Actual)
- Last update posted
- May 8, 2018
2014
United States locations
- U.S. sites
- 22
- U.S. states
- 15
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Precision Trials/New Horizons Women's Care | Chandler | Arizona | 85224 | — |
| Precision Clinical Trials/Arizona Wellness Center for Women | Phoenix | Arizona | 85032 | — |
| Visions Clinical Research | Tucson | Arizona | 85712 | — |
| California Family Health Council | Berkeley | California | 94710 | — |
| California Family Health Council | Los Angeles | California | 90010 | — |
| Clinical Research Consulting | Milford | Connecticut | 06460 | — |
| Nature Coast Clinical Research | Crystal River | Florida | 34429 | — |
| Comprehensive Clinical Trials, LLC | West Palm Beach | Florida | 33409 | — |
| Cypress Medical Research Center | Wichita | Kansas | 67226 | — |
| Women's Clinic of Lincoln, P.C. | Lincoln | Nebraska | 68510 | — |
| Lawrence OB-Gyn Clinical Research | Lawrenceville | New Jersey | 08648 | — |
| Suffolk OBGYN | Port Jefferson | New York | 11777 | — |
| Wake Research Associates | Raleigh | North Carolina | 27615 | — |
| Lyndhurst Clinical Research | Winston-Salem | North Carolina | 27103 | — |
| University of Cincinnati Physicians Company | Cincinnati | Ohio | 45229 | — |
| HWC Women's Research Center | Englewood | Ohio | 45322 | — |
| Vista Clinical Research | Columbia | South Carolina | 29201 | — |
| Chattanooga Medical Research | Chattanooga | Tennessee | 37404 | — |
| Methodist Charlton Medical Center | DeSoto | Texas | 75115 | — |
| The Woman's Hospital of Texas Clinical Research Center | Houston | Texas | 77054 | — |
| PRO/Salt Lake Women's Center | Sandy City | Utah | 84070 | — |
| Tidewater Clinical Research | Virginia Beach | Virginia | 23456 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02019589, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 8, 2018 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02019589 live on ClinicalTrials.gov.