NCT03967964

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

Prospective, Randomized, Open-label and Comparative Study to Determine the Pharmacokinetic Parameters of Vaginal Rings That Contain DHEA, Testosterone, or the Combination of Both Androgens, in Comparison With Oral Administration of DHEA and Transdermal Administration of Testosterone, in Postmenopausal Women

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Laboratorios Andromaco S.A. · Industry
• Sex: Female
• Age: 40 Years – 60 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2015-11-20
• Primary completion: 2016-07-15
• Completion: 2016-07-15
• First posted: 2019-05-30
• Last updated: 2019-05-30

Locations

1 site across 1 country: Chile