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NCT00089414 · ClinicalTrials.gov registry record · Phase 2
Treatment of Menstrually Related Disorders With Continuous v. Interrupted Oral Contraceptives
A Phase 2 study, sponsored by National Institute of Mental Health (NIMH).
- Terminated
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
NCT00089414: Clinical Trial Phase 2 study, sponsored by National Institute of Mental Health (NIMH).
NCT00089414 is a Phase 2 study that was terminated before completion, run by National Institute of Mental Health (NIMH). The registered enrollment target is 5 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00089414, a Phase 2 study, was terminated before completion, sponsored by National Institute of Mental Health (NIMH).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
Study Summary
This study will determine whether uninterrupted treatment with birth control pills over several menstrual cycles prevents severe premenstrual syndrome (PMDD). Previous studies have shown that the hormones estrogen and progesterone regulate mood in women with MRMD. This study will use various treatment regimens with birth control pills and placebo (sugar pill) to clarify the relationships among estrogen and progesterone, the menstrual cycle, and mood. Healthy women between 18 and 45 years of age who menstruate may be eligible for this 15-week study. Candidates are screened with a physical examination, blood and urine tests, an electrocardiogram, and 3 months of symptoms ratings to confirm MRMD. Participants are randomly assigned to one of three treatment groups. Group 1 takes a birth control pill every day and on three occasions takes a placebo capsule. Group 2 takes a birth control pill most but not all days and on three occasions takes a placebo capsule. Group 3 takes a birth control pill every day and on three occasions takes another medication called CDB-2914 that causes menstrual bleeding to occur. Participants come to the NIH clinic every other week for blood tests and measurement of vital signs (blood pressure, pulse, and temperature) and to complete symptoms ratings scales. Subjects who develop breakthrough bleeding (menstruation earlier than expected) will have a transvaginal ultrasound. For this procedure, a probe is inserted into the vagina for about 10 minutes. The probe gives off and receives sound waves that can be used to form a picture of the endometrium (lining of the uterus). ...
Primary Outcome
The PMTS observer scales assess symptoms in ten different domains including irritability-hostility; tension; efficiency; dysphoria; moodiness; motor coordination; mental-cognitive functioning; eating habits; sexual drive and activity; physical symptoms and social impairment. They have been used to measure premenstrual symptom severity and response to treatment in several clinical trials and prevalence studies. Score ranges from no symptoms to severe symptoms on a scale of 0 to 6, with 0 being no
Interventions
- DRUG Placebo
- DRUG CDB 2914
- DRUG Ethinyl Estradiol/Drospirenone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2004-07 |
| Est. Completion | 2010-06 |
| Phase | Phase 2 |
Why NCT00089414 stopped before completion
NCT00089414 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00089414 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00089414 about?
NCT00089414 is a clinical study titled "Treatment of Menstrually Related Disorders With Continuous v. Interrupted Oral Contraceptives". This study will determine whether uninterrupted treatment with birth control pills over several menstrual cycles prevents severe premenstrual syndrome (PMDD). Previous studies have shown that the hormones estrogen and progesterone regulate mood in women with MRMD. This study will use various treatm...
What is the current status of trial NCT00089414?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2004-07. Estimated completion is 2010-06.
What interventions are being tested in trial NCT00089414?
The interventions under investigation include: Placebo (DRUG), CDB 2914 (DRUG), Ethinyl Estradiol/Drospirenone (DRUG).
Who is sponsoring clinical trial NCT00089414?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00089414's enrollment target sits among peer trials
5 2000th of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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