Status:
TERMINATED
Impact of Oral Contraceptives on GABA and Neurosteroids
Lead Sponsor:
Yale University
Conditions:
Healthy
Eligibility:
FEMALE
18-42 years
Brief Summary
Thus, the proposed study has the following Specific Aims and Hypotheses: 1. To determine in menstruating women ages 18-45 whether an OCP containing ethinyl estradiol (EE) and the progestin ethinydiol...
Detailed Description
Approximately 11.6 million women in the United States use oral contraceptives (OCs) each year. The vast majority of OCs combine both estrogen and a type of progestin, or progesterone-like substance in...
Eligibility Criteria
Inclusion
- Aged 18 - 42 years old and able to give voluntary written informed consent.
- Willing to complete a daily log of mood symptoms for 3 consecutive menstrual cycles.
- Be off of OCPs for at least 3 menstrual periods prior to beginning the study and be willing to go on OCPs for the study.
- Provide documentation of a normal PAP smear, pelvic and breast examination within the previous 12 months prior to enrollment.
- Have regular menstrual cycles 28 to 32 days in length prior to enrollment. The screening cycle must be ovulatory as confirmed by plasma progesterone levels of \>3 ng/ml during the luteal phase.
- Negative pregnancy blood test at admission; negative urine pregnancy test on the MRS testing day.
Exclusion
- Presence of any DSM-IV Axis I disorder, excepting possible mild to moderate PMS/PMDD, within the previous 12 months.
- Lifetime history of any psychotic disorder, including bipolar disorder.
- Meeting DSM-IV criteria for psychoactive substance (including nicotine) abuse/dependence within the preceding 6 months.
- A history of serious medical or neurological illness, including (but not limited to) major cardiovascular disease, hypertension (SBP \> 140 mm Hg and DBP \> 90 mm Hg), intracranial mass lesions, seizure disorder, severe hepatic or renal disease, unstable endocrine or metabolic disease, unstable hematologic disease, gynecologic cancer and gallbladder disease, venous thromboembolism, and stroke.
- Diabetes if present with one other cardiovascular risk factor such as hypercholesterolemia or hypertension.
- Hypercholesterolemia if LDL \> 160 mg/dl.
- Use of any psychotropic medication within the previous month.
- Alcohol consumption greater than 7 drinks/week.
- Current pregnancy or planning to become pregnant during the course of the study.
- Metallic implants.
- History of or suspected claustrophobias.
- Migraine headaches if \> 35 yo.
- Weigh \>300 lbs (the 4T magnet has a weight limit \<300 lbs)
Key Trial Info
Start Date :
August 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00656318
Start Date
August 1 2008
End Date
March 1 2009
Last Update
August 25 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Yale University School of Medicine
New Haven, Connecticut, United States, 06511