A Study to Investigate Biomarkers of Skin Androgenization... | NCT00969163

Studies
A Study to Investigate Biomarkers of Skin Androgenization Following Testosterone Administration (0000-015)(COMPLETED).

NCT00969163

Sponsor

Merck Sharp & Dohme LLC

Status

Completed

Last Update Posted

Sep 4, 2014Estimated

Enrollment

30Actual

Phase

Phase 1

Conditions

Skin Androgenization

Interventions

testosterone gel
Comparator: placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2004

Primary Completion Date

Apr 2005Actual

Completion Date

Jun 2005Actual

First Submitted Date

Aug 31, 2009

First Submission Date that Met QC Criteria

Aug 31, 2009

First Posted Date

Sep 1, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 3, 2014

Last Update Posted Date

Sep 4, 2014Estimated

Description Module

Brief Summary

Postmenopausal women will receive testosterone gel or matching placebo gel daily. Sebum excretion rates will be measured before and after 6 weeks of treatment.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	2.5 mg testosterone gel	Drug: testosterone gel
2	Experimental	300 ug testosterone gel	Drug: testosterone gel
3	Placebo Comparator	placebo gel	Drug: Comparator: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
testosterone gel	Drug	300 ug or 2.5 mg transdermal testosterone gel daily for 6 weeks	1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
serum free testosterone concentrations following multiple doses of AndroGel		6 weeks

Secondary Outcomes

Measure	Description	Time Frame
mean percent change from baseline in sebum excretion		6 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject is at least 3 years postmenopausal
Subject is in good general health
Subject is willing to avoid excess alcohol or strenuous physical activity during the study

Exclusion Criteria:

Subject has donated a unit of blood or has taken an investigational drug in another clinical trial in the last 4 weeks
Subject is a regular user of any illicit drugs
Subject drinks excessive amounts of coffee, tea or cola
Subject has used an estrogen or progestogens hormone replacement therapy in the past 6 months
Subject has a history of cancer
Subject has acne

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Medical Monitor	Merck Sharp & Dohme LLC	Study Director

Intervention Browse Module

MeSH Terms

ID	Term
D013739	Testosterone

Ancestor Terms

ID	Term
D000737	Androstenols
D000736	Androstenes
D000731	Androstanes
D013256	Steroids
D000072473

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Type	Description	Link
MK0000-015
2009_654