NCT00551785

Brief Summary

The primary objective of the study is to assess the risks of testosterone transdermal patch use in a representative study population. The primary clinical outcome of interest is breast cancer.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
328

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 31, 2007

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

March 25, 2015

Status Verified

March 1, 2015

Enrollment Period

4.8 years

First QC Date

October 30, 2007

Last Update Submit

March 24, 2015

Conditions

OvariectomyHysterectomyHypoactive Sexual Desire Disorder

Keywords

Hypoactive Sexual Desire DisorderMenopauseAndrogen

Outcome Measures

Primary Outcomes (1)

  • gynecological cancer; serious cardiovascular diseases

    Time to event analysis within 8 years

Study Arms (2)

1

Women prescribed Intrinsa and estrogen therapy

2

Women prescribed estrogen therapy

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women prescribed estrogen therapy or estrogen therapy in combination with Intrinsa

You may qualify if:

  • All women with bilateral oophorectomy and hysterectomy who receive a new prescription for the study medication or who were prescribed it for a period of six months or less before study entry

You may not qualify if:

  • Women who at baseline have used Intrinsa® or the new estrogen therapy for more than six months
  • Women who do not consent to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Epidemiology and Health Research

Berlin, 10115, Germany

Location

MeSH Terms

Conditions

Sexual Dysfunctions, Psychological

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Klaas Heinemann, MD, PhD

    Center for Epidemiology and Health Research, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 30, 2007

First Posted

October 31, 2007

Study Start

September 1, 2007

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

March 25, 2015

Record last verified: 2015-03

Locations

DE(1)