NCT01208038

Brief Summary

The purpose of this study is to examine the effect of the testosterone patch, in addition to hormone replacement therapy (HRT), on blood vessel walls, insulin levels and sexual desire.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

3 active sites

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

First Submitted

Initial submission to the registry

September 22, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 23, 2010

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
7.9 years until next milestone

Results Posted

Study results publicly available

January 2, 2020

Completed
Last Updated

January 2, 2020

Status Verified

December 1, 2019

Enrollment Period

11 months

First QC Date

September 22, 2010

Results QC Date

May 16, 2019

Last Update Submit

December 13, 2019

Conditions

Hypoactive Sexual Desire Disorder

Keywords

Hypoactive sexual desire disorder

Outcome Measures

Primary Outcomes (2)

  • Arterial Compliance - Augmentation Index

    Peripheral pressure waveforms were captured using radial artery application tonometry via the SphygmoCor apparatus (AtCor Medical Ltd., Sydney, Australia; software version 8.0). The central (ascending aortic) pressure waveform was then derived from an averaged peripheral waveform using a validated, transfer function. The augmentation index (AIx), which gives a composite measure of wave reflection and systemic arterial stiffness can then be calculated by analysis of the central waveform. Aix was defined as the difference between the first and second systolic peaks of the central pressure waveform, expressed as a percentage of the central pulse pressure.

    12 weeks from baseline

  • Endothelial Function

    Reactive Hyperaemia Index (RHI) was calculated automatically by the EndoPAT 2000 computer algorithm from the ratio of pulse wave amplitude before and after ischemia, compared to the control arm. Official reference values do not exist however a lower RHI (\<2.0) is usually considered indicative of endothelial dysfunction.

    12 weeks from baseline

Secondary Outcomes (2)

  • Insulin Resistance - HOMA-IR

    12 weeks from baseline

  • Libido - B-PFSF Score

    12 weeks from baseline

Study Arms (1)

Testosterone

EXPERIMENTAL

Testosterone transdermal patch 300micrograms, twice weekly for 12 weeks

Drug: Intrinsa Transdermal testosterone patch

Interventions

Intrinsa Transdermal testosterone patchDRUG

300 microgram transdermal testosterone patch, applied twice weekly for 12 weeks

Also known as: Intrinsa
Testosterone

Eligibility Criteria

Age45 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy postmenopausal women
  • to 70 years of age
  • on HRT and willing to continue the same HRT regimen for the next 6 months
  • are in a stable relationship which was started at least 6 months ago
  • continue on any concomitant medications without any change during the study
  • give informed consent.

You may not qualify if:

  • have dyspareunia
  • have received testosterone implants within the last 12 months or other androgen therapy within the last 6 months
  • have received any medications which may interfere with the study (SSRI, anti-androgens, PDE5 inhibitors, DHEA, SERMS)
  • have a significant psychiatric disorder
  • have a history of breast cancer
  • have diabetes, thromboembolic disorders, cardiovascular disease, any condition affecting carbohydrate metabolism, uncontrolled hypertension and uncontrolled hyperlipidaemia
  • are on tibolone (due to its androgenic effect).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Chelsea and Westminster Hospital

London, SW10 9NH, United Kingdom

Location

Queen Charlotte's and Chelsea Hospital

London, W14 0HS, United Kingdom

Location

Royal Brompton Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Sexual Dysfunctions, Psychological

Interventions

Intrinsa

Condition Hierarchy (Ancestors)

Mental Disorders

Results Point of Contact

Title
Dr Kate Maclaran
Organization
Chelsea and Westminster NHS Trust
kate.maclaran@nhs.net
020 3315 3000

Study Officials

  • Nick Panay, MBBS

    Imperial College Healthcare NHS Trust

    PRINCIPAL INVESTIGATOR

  • John C Stevenson, MBBS

    Royal Brompton and Harefield NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2010

First Posted

September 23, 2010

Study Start

March 1, 2011

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

January 2, 2020

Results First Posted

January 2, 2020

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

GB(3)