Treatment of Menstrually Related Disorders With Continuous v. Interrupted Oral Contraceptives
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ClinicalTrials.gov Identifier: NCT00089414 |
Recruitment Status :
Terminated
(Informed by manufacturer that CDB-2914 crosses blood-brain barrier invalidating Arm #3 of protocol.)
First Posted : August 5, 2004
Results First Posted : January 2, 2017
Last Update Posted : August 25, 2017
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Tracking Information | ||||
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First Submitted Date ICMJE | August 4, 2004 | |||
First Posted Date ICMJE | August 5, 2004 | |||
Results First Submitted Date ICMJE | January 14, 2013 | |||
Results First Posted Date ICMJE | January 2, 2017 | |||
Last Update Posted Date | August 25, 2017 | |||
Study Start Date ICMJE | July 2004 | |||
Actual Primary Completion Date | June 2010 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Change in Premenstrual Tension Syndrome Scale (PMTS) Factors Associated With Premenstrual Symptoms. [ Time Frame: Every 2 weeks for 3 months ] 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 symptoms and 6 being severely symptomatic.
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Original Primary Outcome Measures ICMJE | Not Provided | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Treatment of Menstrually Related Disorders With Continuous v. Interrupted Oral Contraceptives | |||
Official Title ICMJE | The Treatment of Menstrually-Related Mood Disorders With Extended Versus Interrupted Oral Contraceptives | |||
Brief 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). ... |
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Detailed Description | Results from previous protocols (#90-M-0088 and 92-M-0174) have demonstrated that women with menstrually-related mood disorder (MRMD), but not women lacking this disorder, experience mood deterioration within approximately one to two weeks after exposure to either estradiol or progesterone in the context of gonadal suppression (induced by use of the depot gonadotropin releasing hormone agonist leuprolide acetate). Preliminary results of protocol 00-M-0103 suggest that this hormone-induced depression occurs consequent to changes in gonadal steroid levels and not to simple exposure to basal levels above a critical threshold. Additionally, continued administration of hormone for three months resulted in no further symptoms subsequent to the initial precipitated episode. These data suggest the potential therapeutic benefit of extended oral contraceptive (OC) regimens with reduced pill-free intervals in MRMD to minimize the mood destabilizing effects of changing hormone levels. In this protocol we examine whether the effects of 15 weeks of continuous oral contraceptive administration causes a remission of symptoms in women with MRMD. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE |
5 | |||
Original Enrollment ICMJE |
54 | |||
Actual Study Completion Date ICMJE | June 2010 | |||
Actual Primary Completion Date | June 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE |
EXCLUSION CRITERIA: Any patient with a current axis I psychiatric diagnosis will be excluded from participating in this protocol. Subjects taking psychotropic agents (e.g. antidepressants, anxiolytics or mood stabilizers) will likewise be excluded from the study. Women who have received glucocorticoid or megestrol therapy within the last year (and thus may experience residual suppression of the compensatory HPA axis response to CDB-2914-induced glucocorticoid receptor antagonism) will be also excluded, albeit almost entirely on theoretical grounds. Women who have any chronic medical conditions or are taking medications will be excluded. Women who have a medical condition or are taking any chronic medications that may increase serum potassium levels will also be excluded. Those patients who would be uncomfortable with extending the length of their menstrual cycles will not be enrolled in this study and will either be offered participation in another study or an outside referral for treatment in the community. The following conditions will constitute contraindications to treatment with continuous oral contraception or the use of the progesterone antagonist, CDB-2914, and will preclude a patient's participating in this protocol:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 45 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00089414 | |||
Other Study ID Numbers ICMJE | 040221 04-M-0221 |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) ) | |||
Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | National Institutes of Health Clinical Center (CC) | |||
Verification Date | July 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |