This study is NOT currently recruiting participants.
Number
92-M-0174
Sponsoring Institute
National Institute of Mental Health (NIMH)
Recruitment Detail
Type: Completed Study; data analyses ongoing Gender: Female Min Age: 18 Max Age: 50
Referral Letter Required
No
Population Exclusion(s)
Male;Children
Keywords
Behavior; Brain Function; Progesterone; Central Nervous System Function; GnRH Agonist
Recruitment Keyword(s)
None
Condition(s)
Healthy Volunteers
Investigational Drug(s)
Leuprolide Acetate 3.75 mg Depot Lupron Estrogel
Investigational Device(s)
Intervention(s)
Drug: Leuprolide Acetate 3.75 Drug: Estrogel Drug: Progesterone Drug: Placebo suppository Drug: Placebo patch
Supporting Site
National Institute of Mental Health
The purpose of this study is to evaluate how low levels of estrogen and progesterone (that occur during treatment with leuprolide acetate) compare to menstrual cycle levels of estrogen and progesterone (given during individual months of hormone add-back) on a variety of physiologic measures (brain imaging, stress testing, etc.) in healthy volunteer women without PMS.
This study will investigate effects of reproductive hormones by temporarily stopping the menstrual cycle with leuprolide acetate and then giving, in sequence, the menstrual cycle hormones progesterone and estrogen. Tests (such as brain imaging or stress testing, etc.) will be performed during the different hormonal conditions (low estrogen and progesterone, progesterone add-back, estrogen add-back). The results of these studies will be compared between women without PMS and women with PMS (see also protocol 90-M-0088).
At study entry, participants will undergo a physical examination. Blood, urine, and pregnancy tests will be performed. Cognitive functioning and stress response will be evaluated during the study along with brain imaging and genetic studies.
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INCLUSION CRITERIA: Volunteers participating in this study will be women meeting the following criteria: Between the ages of 18 and 50 years, Not pregnant, In good medical health, Medication free, No history of menstrual-related mood or behavioral disturbances. Additionally, we will recruit a subsample of 20 asymptomatic women who will meet all inclusion and exclusion criteria in this protocol except they will have a history of a past major depressive episode. Finally, a third sample of 10 women who meet all the inclusion and exclusion criteria listed above for this protocol will be recruited to establish the dose range of transdermal estrogen gel for this and related protocols (i.e., 90-M-0088 and 05-M-0059). EXCLUSION CRITERIA: The following conditions will constitute contraindications to treatment with hormonal therapy and will preclude a subject's participation in this protocol: Current Axis I psychiatric diagnosis (with the exception of this women with a past major depression who will be studied on this protocol); History consistent with endometriosis; Diagnosis of ill-defined, obscure pelvic lesions, particularly undiagnosed ovarian enlargement; Hepatic disease as manifested by abnormal liver function tests; History of mammary carcinoma; History of pulmonary embolism or phlebothrombosis; Undiagnosed vaginal bleeding; Porphyria; Diabetes mellitus; History of malignant melanoma; Cholecystitis or pancreatitis; Cardiovascular or renal disease; Pregnancy; Any woman meeting the Stages of Reproductive Aging Workshop Criteria (STRAW) for the perimenopause (129). Specifically, we will exclude any woman with an elevated plasma follicle stimulating hormone (FSH) level (greater than or equal to 14 IU/L) and with menstrual cycle variability of > 7 days different from their normal cycle length. National Institute of Mental Health (NIMH) employees/staff and their immediate family members will be excluded from the study per NIMH policy. Subjects taking birth control pills will be excluded from the study. Subjects taking diuretics, prostaglandin inhibitors, or pyridoxine (putative treatments for MRMD) will similarly be excluded from the study, as will patients taking psychotropic agents (e.g., lithium carbonate, tricyclic antidepressants). All subjects will be required to use non-hormonal forms of birth control (e.g., barrier methods) to avoid pregnancy during this study. Participants who have an active condition that places them at an increased risk for osteoporosis will be excluded from this protocol.
Volunteers participating in this study will be women meeting the following criteria:
Between the ages of 18 and 50 years,
Not pregnant,
In good medical health,
Medication free,
No history of menstrual-related mood or behavioral disturbances.
Additionally, we will recruit a subsample of 20 asymptomatic women who will meet all inclusion and exclusion criteria in this protocol except they will have a history of a past major depressive episode.
Finally, a third sample of 10 women who meet all the inclusion and exclusion criteria listed above for this protocol will be recruited to establish the dose range of transdermal estrogen gel for this and related protocols (i.e., 90-M-0088 and 05-M-0059).
EXCLUSION CRITERIA:
The following conditions will constitute contraindications to treatment with hormonal therapy and will preclude a subject's participation in this protocol:
Current Axis I psychiatric diagnosis (with the exception of this women with a past major depression who will be studied on this protocol);
History consistent with endometriosis;
Diagnosis of ill-defined, obscure pelvic lesions, particularly undiagnosed ovarian enlargement;
Hepatic disease as manifested by abnormal liver function tests;
History of mammary carcinoma;
History of pulmonary embolism or phlebothrombosis;
Undiagnosed vaginal bleeding;
Porphyria;
Diabetes mellitus;
History of malignant melanoma;
Cholecystitis or pancreatitis;
Cardiovascular or renal disease;
Pregnancy;
Any woman meeting the Stages of Reproductive Aging Workshop Criteria (STRAW) for the perimenopause (129). Specifically, we will exclude any woman with an elevated plasma follicle stimulating hormone (FSH) level (greater than or equal to 14 IU/L) and with menstrual cycle variability of > 7 days different from their normal cycle length.
National Institute of Mental Health (NIMH) employees/staff and their immediate family members will be excluded from the study per NIMH policy.
Subjects taking birth control pills will be excluded from the study.
Subjects taking diuretics, prostaglandin inhibitors, or pyridoxine (putative treatments for MRMD) will similarly be excluded from the study, as will patients taking psychotropic agents (e.g., lithium carbonate, tricyclic antidepressants).
All subjects will be required to use non-hormonal forms of birth control (e.g., barrier methods) to avoid pregnancy during this study.
Participants who have an active condition that places them at an increased risk for osteoporosis will be excluded from this protocol.
Principal Investigator
Referral Contact
For more information: