Impact of Oral Contraceptives on GABA and Neurosteroids

Stopped early

Conditions studied: Healthy

In brief

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 diacetate (ED) increases cortical GABA concentrations as measured using proton magnetic resonance spectroscopy (1H-MRS) above that of an OCP containing EE and the progestin norethindrone (NOR). 2. To determine the relationship between changes in occipital GABA concentrations with acute OCP administration and negative affect with chronic OCP administration over two menstrual cycles.

Key facts

Study ID

NCT00656318

Run by

Yale University

People needed

6

Starts

2008-08-01

Expected to finish

2009-03-01

Last updated by the study team

2009-08-25

Who can join

Age: 18 and older, up to 42. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• Yale University School of Medicine — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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