Clinical Trial: 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
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
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
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.)
Detailed Summary:
Sponsor: TherapeuticsMD
Current Primary Outcome: • The proportion of subjects at Cycle 3 Day 24 ± 1 day on active treatment compared to placebo with complete secretory activity on endometrial biopsy. [ Time Frame: 3 Cycles ]
Original Primary Outcome: Same as current
Current Secondary Outcome: • 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. [ Time Frame: 3 cycles ]
Original Secondary Outcome: Same as current
Information By: TherapeuticsMD
Dates:
Date Received: December 18, 2013
Date Started: December 2013
Date Completion:
Last Updated: November 19, 2014
Last Verified: November 2014