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NCT00374387 Clinical Trial

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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00374387
Other study ID # 2006/309
Secondary ID
Status Completed
Phase N/A
First received September 8, 2006
Last updated March 30, 2011
Start date September 2006
Est. completion date March 2011

Study information
Verified date March 2011
Source University Hospital, Ghent
Contact n/a
Is FDA regulated No
Health authority Belgium: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date March 2011
Est. primary completion date August 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Nuvaring

• low-dose combination pill

• minipill

Locations
Country Name City State
Belgium University Hospital Ghent Ghent

Sponsors (2)
Lead Sponsor Collaborator
University Hospital, Ghent Fund for Scientific Research, Flanders, Belgium

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Parameters about sexual desire and psychosocial, relational en sexual parameters.
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