Ignite Creation Date:
2024-05-06 @ 2:19 AM
Last Modification Date:
2024-10-26 @ 11:17 AM
Study NCT ID:
NCT02019589
Status:
TERMINATED
Last Update Posted:
2018-05-08
First Post:
2013-12-18
Brief Title:
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
Sponsor:
TherapeuticsMD
Organization:
TherapeuticsMD
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPRY
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
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 Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None