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Study of Serum Testosterone Levels in Non-dosed Females After Secondary Exposure

S

Solvay

Status and phase

Completed
Phase 1

Conditions

Hypogonadism

Treatments

Drug: Testosterone gel 1.62%

Study type

Interventional

Funder types

Industry

Identifiers

NCT00998933
S176.1.009

Details and patient eligibility

About

To further characterize the transfer potential of marketed testosterone gel and new 1.62% formulation.

Enrollment

24 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy male and female volunteers, with a BMI 20-35 kg/m2 (males) and 20-30 kg/m2 (females).

Exclusion criteria

  • Males: history, current or suspected prostate or breast cancer.
  • Female: pregnant or lactating.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

24 participants in 1 patient group

1
Experimental group
Treatment:
Drug: Testosterone gel 1.62%

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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