Psychosocial and Physiological Mechanisms in the Effect of Hormonal Contraception on the Female Sexual Desire

This study is ongoing, but not recruiting participants.

First Received: September 8, 2006 Last Updated: April 16, 2009 History of Changes

Sponsor:	University Hospital, Ghent
Collaborator:	Fund for Scientific Research, Flanders, Belgium
Information provided by:	University Hospital, Ghent
ClinicalTrials.gov Identifier:	NCT00374387

Purpose

75 heterosexual women are asked to use 3 different types of contraception (Nuvaring, low-dose combination pill, minipill), each during 3 months. On a monthly basis, questionnaires are filled out about sexual desire and psychosocial, relational en sexual parameters. Also the sexual desire of the partner is questioned. On a three-monthly basis, blood samples are drawn to determine changes in hormonal parameters (one sample per product period).

75 lesbian women are doing the same trial, but during an extra 3 months period, they are asked to have their natural menstrual cyclus as a control condition. Blood samples during these extra months will be drawn at the third or fourth day after start of the menses.

Condition	Intervention
Healthy	Drug: Nuvaring Drug: low-dose combination pill Drug: minipill

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
Official Title:	Psychosocial and Physiological Mechanisms in the Effect of Hormonal Contraception on the Female Sexual Desire

Resource links provided by NLM:

MedlinePlus related topics: Birth Control

U.S. FDA Resources

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:

Parameters about sexual desire and psychosocial, relational en sexual parameters.

Estimated Enrollment:	150
Study Start Date:	September 2006
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Heterosexual or lesbian women
Aged between 18 and 45 years
Stable monogameous relationship
Normal menstrual cyclus

Exclusion Criteria:

Polycystic ovarial syndrome
Normal exclusion criteria for the use of contraception
Use of medication known to influence sexual desire and/or androgen levels
Women who wants to become pregnant, are pregnant or breastfeeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00374387

Locations

Belgium
University Hospital Ghent
Ghent, Belgium, 9000

Sponsors and Collaborators

University Hospital, Ghent

Fund for Scientific Research, Flanders, Belgium

Investigators

Principal Investigator:

Petra De Sutter, MD, PhD

University Hospital, Ghent

More Information

Additional Information:

Website University Hospital Ghent This link exits the ClinicalTrials.gov site

Website about this study This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University Hospital Ghent ( Petra De Sutter )
Study ID Numbers:	2006/309
Study First Received:	September 8, 2006
Last Updated:	April 16, 2009
ClinicalTrials.gov Identifier:	NCT00374387 History of Changes
Health Authority:	Belgium: Institutional Review Board

Keywords provided by University Hospital, Ghent:

Healthy women

ClinicalTrials.gov processed this record on February 08, 2010