NCT00374387

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Sep 2006

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 11, 2006

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

March 31, 2011

Status Verified

March 1, 2011

Enrollment Period

2.9 years

First QC Date

September 8, 2006

Last Update Submit

March 30, 2011

Conditions

Healthy

Keywords

Healthy women

Outcome Measures

Primary Outcomes (1)

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

Interventions

NuvaringDRUG
low-dose combination pillDRUG
minipillDRUG

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Polycystic ovarial syndrome
  • Use of medication known to influence sexual desire and/or androgen levels
  • Women who wants to become pregnant, are pregnant or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Links

MeSH Terms

Interventions

NuvaRing

Study Officials

  • Petra De Sutter, MD, PhD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2006

First Posted

September 11, 2006

Study Start

September 1, 2006

Primary Completion

August 1, 2009

Study Completion

March 1, 2011

Last Updated

March 31, 2011

Record last verified: 2011-03

Locations

BE(1)