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Pharmacokinetics of a Novel Vaginal Delivery System for Testosterone and Dehydroepiandrosterone (DHEA)

NCT03967964 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2019-05-30

No results posted yet for this study

Summary

This study was performed to determine the pharmacokinetic parameters of vaginal rings that contain DHEA, testosterone, or combinations of both androgens, in comparison to the oral administration of DHEA and the transdermal administration of testosterone.

Conditions

  • Pharmacokinetics
  • Hormone Deficiency

Interventions

DRUG

Dehydroepiandrosterone 2.2 g

Vaginal ring with 2.2 grams DHEA.

DRUG

Dehydroepiandrosterone 1.5 g/Testosterone 25 mg

Vaginal ring with DHEA 1.5 grams/Testosterone 25 mg.

DRUG

Testosterone

Vaginal ring with 35 mg testosterone.

DRUG

Testosterone Topical Gel

Gel containing 1% testosterone.

DRUG

Dehydroepiandrosterone Oral Capsule

Capsule containing 25 mg DHEA

Sponsors & Collaborators

  • Laboratorios Andromaco S.A.

    lead INDUSTRY

Principal Investigators

  • Grünenthal Study Director · Grünenthal GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-20
Primary Completion
2016-07-15
Completion
2016-07-15

Countries

  • Chile

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03967964 on ClinicalTrials.gov