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

• Sponsor: University Hospital, Ghent (Other)
• Overall Status: Completed
• CT.gov ID: NCT00374387
• Collaborator: Fund for Scientific Research, Flanders, Belgium (Other)
• Enrollment: 150
• Location: 1
• Duration (Months): 53.9
• Patients Per Site Per Month: 2.8

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Healthy	Drug: Nuvaring; Drug: low-dose combination pill; Drug: minipill	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Psychosocial and Physiological Mechanisms in the Effect of Hormonal Contraception on the Female Sexual Desire
• Study Start Date: Sep 1, 2006
• Actual Primary Completion Date: Aug 1, 2009
• Actual Study Completion Date: Mar 1, 2011

Outcome Measures

Primary Outcome Measures

1. Parameters about sexual desire and psychosocial, relational en sexual parameters. []

Eligibility Criteria

Criteria

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

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Website University Hospital Ghent

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00374387
• Other Study ID Numbers: 2006/309
• First Posted: Sep 11, 2006
• Last Update Posted: Mar 31, 2011
• Last Verified: Mar 1, 2011

• Keywords provided by , ,: Healthy women
• Additional relevant MeSH terms: NuvaRing

Study Results

No Results Posted as of Mar 31, 2011