Trial Outcomes & Findings for Impact of GABA-Enhancing Agents on Cortical GABA Concentrations Across the Menstrual Cycle in Women (NCT NCT00676026)

NCT ID: NCT00676026

Last Updated: 2017-06-01

Results Overview

This study was conducted at Yale University almost two decades ago. Our group at the University of Pennsylvania only has very basic information about this study. This includes the number of participants, which was 8, and the fact that no adverse events occurred. Staff members at the University of Pennsylvania do not have access to any additional study data. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania and we are unable to contact for additional information.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

8 participants

Primary outcome timeframe

Each medication will be administered 2 times during a 1-month menstrual cycle.

Results posted on

2017-06-01

Participant Flow

Participants were recruited at an outpatient research facility located at Yale University in New Haven, CT.

Participant milestones

Participant milestones
Measure
All Participants
This study was conducted at Yale University almost two decades ago. Our group at the University of Pennsylvania only has very basic information about this study. This includes the number of participants, which was 8, and the fact that no adverse events occurred. Staff members at the University of Pennsylvania do not have access to any additional study data. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania and we are unable to contact for additional information.
Overall Study
STARTED
8
Overall Study
COMPLETED
8
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Impact of GABA-Enhancing Agents on Cortical GABA Concentrations Across the Menstrual Cycle in Women

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: Each medication will be administered 2 times during a 1-month menstrual cycle.

Population: UPenn does not have access to the data collected for this study. We are only using the information entered in the protocol section for very basic details in the results section (i.e, number of participants completed). The original contact person for this protocol is not reachable.

This study was conducted at Yale University almost two decades ago. Our group at the University of Pennsylvania only has very basic information about this study. This includes the number of participants, which was 8, and the fact that no adverse events occurred. Staff members at the University of Pennsylvania do not have access to any additional study data. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania and we are unable to contact for additional information.

Outcome measures

Outcome data not reported

Adverse Events

All Participants

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Cynthia Neill Epperson, M.D.

University of Pennsylvania

Phone: 215-573-8871

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place