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

Merck Sharp & Dohme (MSD) logo

Merck Sharp & Dohme (MSD)

Status and phase

Completed
Phase 1

Conditions

Skin Androgenization

Treatments

Drug: Comparator: placebo
Drug: testosterone gel

Study type

Interventional

Funder types

Industry

Identifiers

NCT00969163
MK0000-015
0000-015
2009_654

Details and patient eligibility

About

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

Enrollment

30 patients

Sex

Female

Ages

50 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

30 participants in 3 patient groups, including a placebo group

1
Experimental group
Description:
2.5 mg testosterone gel
Treatment:
Drug: testosterone gel
2
Experimental group
Description:
300 ug testosterone gel
Treatment:
Drug: testosterone gel
3
Placebo Comparator group
Description:
placebo gel
Treatment:
Drug: Comparator: placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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