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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 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2018-05-08

No results posted yet for this 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.)

Conditions

  • Secondary Amenorrhea

Interventions

DRUG

Progesterone

DRUG

Placebo

Sponsors & Collaborators

  • TherapeuticsMD

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-20
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02019589 on ClinicalTrials.gov