 |
 |
 |
 |
 |
 |
 |
Treatment of Menstrually Related Disorders With Continuous v. Interrupted Oral Contraceptives
This study is currenly Completed patients.
Sponsored by:
National Institute of Mental Health (NIMH)
Purpose
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).
...
Study Type: Intervention
| Condition | Intervention | Phase |
|
Premenstrual Syndrome PMS Premenstrual Dysphoric Disorder PMDD Depression |
Drug: CDB 2914 | Phase 2 |
Study Design:Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Official Title: The Treatment of Menstrually-Related Mood Disorders With Extended Versus Interrupted Oral Contraceptives
Further Study Details:
Expected Total Enrollment:
Study Dates:July 2004 -
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.
Eligibility
Ages Eligible for Study- Min: N/A Max: N/A
Gender: Female
Criteria
INCLUSION CRITERIA (are from protocol 81-M-0126 and are as follows):
Subjects who meet criteria for MRMD are healthy (by physical exam, normal pelvic exam
and pap smear, and normal lab values) and medication free will be included in this
study.
Oral contraceptives (and CDB-2914 in arm #3) will not be administered to any subject
with significant clinical or laboratory abnormalities.
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 megesterol 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:
history of endometriosis, or recent, rapid growth of uterine fibroid tumors (defined
as doubling in size in six month period);
diagnosis of ill-defined, obscure pelvic lesions, particularly undiagnosed ovarian
enlargement;
hepatic disease as manifested by abnormal liver function tests;
history of breast carcinoma;
history of pulmonary embolism or phlebothrombosis;
undiagnosed vaginal bleeding;
porphyria;
history of malignant melanoma;
history of cholecystitis or pancreatitis;
history of hypercholesterolemia, hypertension, diabetes, or renal disease;
recurrent migraine headaches (greater than or equal to 3 per year) in women 35 or
older;
pregnancy or lactation;
cigarette smoking in women 35 or older, or more than 10 cigarettes per day in women
under 35; or
use of oral, injectable, or inhaled glucocorticoids or megesterol within the last
year.
and pap smear, and normal lab values) and medication free will be included in this
study.
with significant clinical or laboratory abnormalities.
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 megesterol 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:
as doubling in size in six month period);
enlargement;
older;
under 35; or
year.
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier: NCT00089414
More Information
Record Last Reviewed:June 2010
Last Updated:July 7, 2010
Record First Recieved:August 4, 2004
ClinicalTrials.gov Identifier:NCT00089414
Health Authority: United States Food and Drug Administration
Information obtained from ClinicalTrials.gov on September 02, 2010
 |
 |