TerminatedPhase 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

United States6 participantsStarted 2014-01-20

Plain-language 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.)

Who can participate

Age range

18 Years – 40 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Be female, premenopausal, 18 to 40 years of age (inclusive, at the time of randomization) * Have secondary amenorrhea, defined as the absence of menstruation for at least 90 days prior to Visit 1 (Cycle 1, Day 1). * Have an intact uterus. * Be otherwise healthy, as judged by the Investigator physician, based on a medical evaluation performed during the screening period prior to the initial dose of Estrace®. The medical evaluation must include: * a normal or non-clinically significant physical examination, including vital signs (sitting blood pressure, heart rate, respiratory rate and temperature). Acceptable sitting systolic blood pressure is \<140 mmHg and diastolic blood pressure is \<90 mmHg at screening. A subject may be taking up to two antihypertensive medications. * a normal or non-clinically significant pelvic examination performed during screening. * a normal or non-clinically significant clinical breast examination performed during screening. An acceptable breast examination is defined as no masses, adenopathy, or other findings identified that are suspicious of malignancy. * a normal or non-clinically significant 12-lead ECG as determined by the Principal Investigator (PI) or medical Sub-Investigator. * Have a negative serum pregnancy test at Screening, and be willing to use an acceptable form of non-hormonal birth control (e.g., barrier method with spermicide) during the study. (The "rhythm method," withdrawal, or an IUD are NOT acc…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

• The proportion of subjects at Cycle 3 Day 24 ± 1 day on active treatment compared to placebo with complete secretory activity on endometrial biopsy.

Timeframe: 3 Cycles

Trial details

NCT IDNCT02019589

SponsorTherapeuticsMD

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-10-31

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