HealthyNCT00656318

Impact of Oral Contraceptives on GABA and Neurosteroids

An observational study of Healthy, run by Yale University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial 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)… Read more about this study

Who is it for?: Ages 18 to 42 years, women onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: oral contraceptive pill (OCP; OCPs)
Type of treatment: Pill or oral medicine
How many people: 6 participants
Where: 1 siteUnited States
Study dates: Aug 2008to Mar 2009
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 42 years
Women only
Healthy volunteers accepted
Adult

Study population: Women between the ages of 18 and 42 with regular menstrual cycles of 28-32 days will be invited to participate in a brain imaging study examining the effects of two different oral contraceptives on cortical GABA levels.

Who may be able to join

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.

Who cannot join

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.

Show all 13Show fewer

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)

Trial locations and contacts

1 site in 1 country.

United States1 site

Yale University School of Medicine
New Haven, Connecticut, 06511

Other trials in United States

About this study

Thus, the proposed study has the following Specific Aims and Hypotheses:

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).
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.

Read the 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.

Conditions: Healthy
Being tested: oral contraceptive pill (OCP; OCPs)
Keywords: women, menses, oral contraceptives, Healthy menstruating females

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

oral contraceptive pill (OCP; OCPs)Other
Also called Zovia 1/35, Necon
Daily administration of oral contraceptive pill for up to 3 months (2 months of daily administration required for the study).

Study groups in NCT00656318
Study group	Role	What they receive
Group 1 (Zovia)		Subjects will be randomized to receive either the oral contraceptive pill (OCP) Zovia or Necon for 2 months. Prior to beginning the OCP, women will undergo 1 imaging scan. Upon completion of the scan they will receive their first dose of their OCP. Three hours later they will undergo a 2nd imaging scan. Each scan last approximately 1 hour and 15 minutes. This test day is typically scheduled on a Saturday, and lasts approximately 7 hours. Upon completion of the Saturday test day, subjects will remain on their OCP for the remainder of that month and continue taking the pill for a 2nd month. At the end of the 2 months on the pill, subjects will have the option of discontinuing the pill or receiving 1 additional month at no charge before being discharged from the study. Receives: Other: oral contraceptive pill (OCP; OCPs)
Group 2 (Necon)		Subjects will be randomized to receive either the oral contraceptive pill (OCP) Zovia or Necon for 2 months. Prior to beginning the OCP, women will undergo 1 imaging scan. Upon completion of the scan they will receive their first dose of their OCP. Three hours later they will undergo a 2nd imaging scan. Each scan last approximately 1 hour and 15 minutes. This test day is typically scheduled on a Saturday, and lasts approximately 7 hours. Upon completion of the Saturday test day, subjects will remain on their OCP for the remainder of that month and continue taking the pill for a 2nd month. At the end of the 2 months on the pill, subjects will have the option of discontinuing the pill or receiving 1 additional month at no charge before being discharged from the study. Receives: Other: oral contraceptive pill (OCP; OCPs)

What is being measured

The primary outcome is the main question the study is designed to answer.

The purpose of this study is to investigate the effect of oral contraceptive pills (OCPs) on cortical GABA concentrations as measured by proton magnetic resonance spectroscopy (1H-MRS) in non-depressed, healthy menstruating women.
Measured: Outcomes will be measured at several points during each participants menstrual cycle.

Secondary outcomes (1)

To determine the impact of OCP use on plasma and cerebral spinal fluid (CSF) levels of estradiol (E2) and progesterone, as well as neurosteroids such as pregnenolone, allopregnanolone, pregnanolone and 5 alpha-dihydroprogesterone (5α-DHP).
Measured: Outcome will be assessed at several time points for each participant.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2008Mar 2009

First posted11 Apr 2008 (estimated)
Study startAug 2008
Primary completionMar 2009
Study completionMar 2009

Why it stopped: Funding withdrawn from study sponsor.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Yale UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00656318
Sponsor's protocol ID: 0701002178
Status last verified: Aug 2009
First submitted: 7 Apr 2008
Last updated: 25 Aug 2009
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of Oral Contraceptives on GABA and Neurosteroids
ClinicalTrials.gov ID: NCT00656318
Acronym / sponsor ID: 0701002178
Conditions: Healthy
Keywords: women, menses, oral contraceptives, Healthy menstruating females
Study type: Observational
Recruitment status: TerminatedReason stopped: Funding withdrawn from study sponsor.
Enrolment: 6 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Study start: Aug 2008
Primary completion: Mar 2009 (actual)
Study completion: Mar 2009 (actual)
First posted: 11 Apr 2008 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Thus, the proposed study has the following Specific Aims and Hypotheses:

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).
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

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Group 1 (Zovia)	–	Other: oral contraceptive pill (OCP; OCPs)Subjects will be randomized to receive either the oral contraceptive pill (OCP) Zovia or Necon for 2 months. Prior to beginning the OCP, women will undergo 1 imaging scan. Upon completion of the scan they will receive their first dose of their OCP. Three hours later they will undergo a 2nd imaging scan. Each scan last approximately 1 hour and 15 minutes. This test day is typically scheduled on a Saturday, and lasts approximately 7 hours. Upon completion of the Saturday test day, subjects will remain on their OCP for the remainder of that month and continue taking the pill for a 2nd month. At the end of the 2 months on the pill, subjects will have the option of discontinuing the pill or receiving 1 additional month at no charge before being discharged from the study.
Group 2 (Necon)	–	Other: oral contraceptive pill (OCP; OCPs)Subjects will be randomized to receive either the oral contraceptive pill (OCP) Zovia or Necon for 2 months. Prior to beginning the OCP, women will undergo 1 imaging scan. Upon completion of the scan they will receive their first dose of their OCP. Three hours later they will undergo a 2nd imaging scan. Each scan last approximately 1 hour and 15 minutes. This test day is typically scheduled on a Saturday, and lasts approximately 7 hours. Upon completion of the Saturday test day, subjects will remain on their OCP for the remainder of that month and continue taking the pill for a 2nd month. At the end of the 2 months on the pill, subjects will have the option of discontinuing the pill or receiving 1 additional month at no charge before being discharged from the study.

Who may qualify

Ages: 18 to 42 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult
Study population: Women between the ages of 18 and 42 with regular menstrual cycles of 28-32 days will be invited to participate in a brain imaging study examining the effects of two different oral contraceptives on cortical GABA levels.

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (13 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
oral contraceptive pill (OCP; OCPs)Also: Zovia 1/35, NeconDaily administration of oral contraceptive pill for up to 3 months (2 months of daily administration required for the study).	Other	Group 1 (Zovia), Group 2 (Necon)

Primary outcome

The purpose of this study is to investigate the effect of oral contraceptive pills (OCPs) on cortical GABA concentrations as measured by proton magnetic resonance spectroscopy (1H-MRS) in non-depressed, healthy menstruating women.
Time frame: Outcomes will be measured at several points during each participants menstrual cycle.

1 secondary outcome

To determine the impact of OCP use on plasma and cerebral spinal fluid (CSF) levels of estradiol (E2) and progesterone, as well as neurosteroids such as pregnenolone, allopregnanolone, pregnanolone and 5 alpha-dihydroprogesterone (5α-DHP).
Time frame: Outcome will be assessed at several time points for each participant.

Results and safety

The study was stopped early (reason given: Funding withdrawn from study sponsor.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2009.

Related trials for Healthy

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

C. Neill Epperson, M.D. principal investigator

Yale University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy, run by Yale University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 25 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Funding withdrawn from study sponsor.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The purpose of this study is to investigate the effect of oral contraceptive pills (OCPs) on cortical GABA concentrations as measured by proton magnetic resonance spectroscopy (1H-MRS) in non-depressed, healthy menstruating women. (time frame: Outcomes will be measured at several points during each participants menstrual cycle.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00656318.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2009.