Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2026-02-28 @ 9:10 PM
Study NCT ID:
NCT00656318
Status:
TERMINATED
Last Update Posted:
2009-08-25
First Post:
2008-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Oral Contraceptives on GABA and Neurosteroids
Sponsor:
Yale University
Organization:
Study Overview
Official Title:
Impact of Oral Contraceptives on GABA and Neurosteroids
Status:
TERMINATED
Status Verified Date:
2009-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding withdrawn from study sponsor.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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.
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.
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 into one pill which is taken daily. Depression or a negative change in mood, apparently resulting from the use of OCs, is thought to be one of the main reasons women miss pills or stop taking their oral contraceptive pills (OCPs) altogether. Clinical observation that some women develop depression when taking progestin only OCs or when adding progestins to menopausal estrogen therapy has led to the speculation that the progestin is the likely culprit of these negative mood changes in women using combined OCPs.
The current study is designed to investigate the role of progestins in the development of mood symptoms in OCP users. Women participating in this study will receive one of two different OCPs for three months. Their mood while taking the OCPs will be compared to their mood prior to using OCPs. In addition, each woman will undergo a brain imaging study after the first dose of their OCP to determine whether acute changes in brain chemistry in response to the OCP predicts change in mood with OCP use. By choosing OCPs with the same estrogen product but 2 different types of progestins we hope to determine whether one type of progestin is more likely to result in negative mood.
Determining factors that contribute to the emergence of depression with OC use is the first step in developing newer oral contraceptives that do not have this health outcome and will ultimately improve compliance with OCP use. Reducing side effects of OCPs is likely to improve compliance and thus decrease the prevalence of unwanted pregnancy.
The current study is designed to investigate the role of progestins in the development of mood symptoms in OCP users. Women participating in this study will receive one of two different OCPs for three months. Their mood while taking the OCPs will be compared to their mood prior to using OCPs. In addition, each woman will undergo a brain imaging study after the first dose of their OCP to determine whether acute changes in brain chemistry in response to the OCP predicts change in mood with OCP use. By choosing OCPs with the same estrogen product but 2 different types of progestins we hope to determine whether one type of progestin is more likely to result in negative mood.
Determining factors that contribute to the emergence of depression with OC use is the first step in developing newer oral contraceptives that do not have this health outcome and will ultimately improve compliance with OCP use. Reducing side effects of OCPs is likely to improve compliance and thus decrease the prevalence of unwanted pregnancy.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: