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NCT02019589 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study, sponsored by TherapeuticsMD.
- Terminated
- Registry status
- Phase 3
- Development phase
- 6
- Enrollment target
NCT02019589 is a Phase 3 study that was terminated before completion, run by TherapeuticsMD. The registered enrollment target is 6 participants.
The verdict
NCT02019589, a Phase 3 study, was terminated before completion, sponsored by TherapeuticsMD.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 6 participants
- Enrollment target
Study 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.)
Interventions
- DRUG Placebo
- DRUG Progesterone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2014-01-20 |
| Est. Completion | 2014-10-31 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02019589
The ClinicalTrials.gov registry entry for NCT02019589 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is TherapeuticsMD, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02019589 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02019589 about?
NCT02019589 is a clinical study titled "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". 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 Peri...
What is the current status of trial NCT02019589?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 6 participants. The study started on 2014-01-20. Estimated completion is 2014-10-31.
What interventions are being tested in trial NCT02019589?
The interventions under investigation include: Placebo (DRUG), Progesterone (DRUG).
Who is sponsoring clinical trial NCT02019589?
This trial is sponsored by TherapeuticsMD, which has 5 total clinical trials registered on ClinicalTrials.gov.
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