CompletedNCT03967964Updated May 30, 2019

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

A Phase 1 interventional study of Dehydroepiandrosterone 2.2 g and Dehydroepiandrosterone 1.5 g/Testosterone 25 mg in Pharmacokinetics and Hormone Deficiency, sponsored by Laboratorios Andromaco S.A.. Completed at 1 site in Chile. Open to female participants aged 40 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-30.

Sponsored by Laboratorios Andromaco S.A. · Phase 1, Interventional, and Treatment

From the registry’s dates

Registered 3 years 6 months after the study started (first participant enrolled Nov 2015, registered May 2019).

Phase: Phase 1
Study type: Interventional
Enrollment: 46
Allocation: Randomized
Ages: 40 Years to 60 Years
Sex: Female

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 studied

Pharmacokinetics
Hormone Deficiency

Keywords

Gynaecology
Obstetrics

In context

Lead sponsor

Laboratorios Andromaco S.A. is the lead sponsor of 19 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 40 Years to 60 Years
Sexes eligible: Female
Accepts healthy volunteers: Yes

Inclusion criteria

Women between 40 to 60 years old.
Postmenopausal with spontaneous amenorrhea of 1 year or more, regardless of follicle stimulating hormone (FSH) levels; or amenorrhea of 6 to 12 months, in which the postmenopausal state will be confirmed with a FSH level of 0.040 international units per milliliter or higher.
Body Mass Index between 19 and 30.
Intact uterus.
Not having received hormone therapy in the month prior to selection.
Adequate veins to conduct serial blood samplings.
Recent Pap smear (not more than 12 months), with a result negative for malignant neoplastic cells, and that contains sufficient endocervical cells for analysis. If the Pap smear was performed more than 12 months ago or cannot be verified through clinical documentation, it must be repeated during the selection process.
Normal mammogram, BI.RADS I or II (American College of Radiology), within the last year. If the mammogram was performed more than 12 months ago or cannot be verified through clinical documentation, it must be repeated during the selection process.
That provide written informed consent.

Exclusion criteria

Exclusion Criteria:

Use at randomization of phenytoin, barbiturates, primidone, carbamazepine, rifampin, griseofulvin, ketoconazole, lipid-lowering agents.
History of diseases such as coronary heart disease, breast cancer, uterine cancer, and/or chronic hepatic disease.
Unconscious volunteers, severely ill, or with mental disability.
Allergy and hypersensitivity to DHEA and/or testosterone.
Untreated or uncontrolled hypertension, with systolic pressure above 140 mm Hg or diastolic pressure above 90 mm Hg.
Current participation in other research at the moment of the screening visit, or having concluded their participation in a previous research in less than 30 days since their last visit.
Pregnant or lactating women; pregnancy must be confirmed with a urine positive human chorionic gonadotropin (HCG) test during screening.
History of vein thrombosis (deep vein thrombosis, pulmonary embolism).
History of arterial thrombosis (myocardial infarction) or prodromic conditions (e.g. transient ischemic attack, angina pectoris).
History of stroke.
History of migraine with focal neurological manifestations.
History of hepatic tumor (benign or malignant).
History of clinical atherosclerosis in first grade relatives (parents, siblings, sons [men less than 55 years old and women less than 65 years old]).
Smoking (5 or more cigarettes a day).
Diabetes mellitus that will be ruled out at screening if fasting glucose is less than 100 mg/dL or between 100 and 125 mg/dL, with Oral Glucose Tolerance Test that rules out diabetes. Diabetes will be confirmed with blood glucose equal to or above 200 mg/dL or 2 fasting glucose tests equal to or above 126 mg/dL.
High density lipopolysaccharide (HDL)-cholesterol below 35 mg/dL.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 46 participants (actual)

Study arms

Experimental
Group 1: AVD
Vaginal ring with 2.2 grams dehydroepiandrosterone (DHEA), wearing time 72 hours
Drug: Dehydroepiandrosterone 2.2 g
Experimental
Group 2: AVT
Vaginal ring with 35 mg testosterone, wearing time 72 hours.
Drug: Testosterone
Experimental
Group 3: AVD+T
Vaginal ring with 1.5 grams DHEA and 25 mg testosterone, wearing time 72 hours.
Drug: Dehydroepiandrosterone 1.5 g/Testosterone 25 mg
Active comparator
Group 4: DHEA capsule
Capsules with 25 mg DHEA, oral administration every 8 hours for a 72-hour period.
Drug: Dehydroepiandrosterone Oral Capsule
Active comparator
Group 5: Testosterone transdermal gel
Testosterone transdermal gel with dosing valve (pump): administration of 3 pump actuations (equivalent to 5 mg of testosterone each) per day (total daily dose 15 mg), on 3 consecutive days (72 hours).
Drug: Testosterone Topical Gel

Interventions

DrugDehydroepiandrosterone 2.2 g
Vaginal ring with 2.2 grams DHEA.
DrugDehydroepiandrosterone 1.5 g/Testosterone 25 mg
Vaginal ring with DHEA 1.5 grams/Testosterone 25 mg.
DrugTestosterone
Vaginal ring with 35 mg testosterone.
DrugTestosterone Topical Gel
Gel containing 1% testosterone.
Also known as: ActiserPump®
DrugDehydroepiandrosterone Oral Capsule
Capsule containing 25 mg DHEA

What researchers measure

Primary outcomes

Testosterone: Area under the serum concentration time curve (AUC0-72)
Serum testosterone was measured pre-dose and at 30 minutes, at 1 hour, 2, 4, 6, 8, 24, 48, and 72 hours after vaginal ring insertion, the transdermal application of the testosterone gel, or after taking DHEA capsules. The AUC0-72 was calculated.
Time frame: Pre-dose and from 30 minutes after administration of the assigned treatment to 72 hours
DHEA: Area under the serum concentration time curve (AUC0-72)
Serum DHEA were measured pre-dose and at 30 minutes, at 1 hour, 2, 4, 6, 8, 24, 48, and 72 hours after vaginal ring insertion, the transdermal application of the testosterone gel, or after taking DHEA capsules. The AUC0-72 was calculated.
Time frame: Pre-dose and from 30 minutes after administration of the assigned treatment to 72 hours
Testosterone: Average serum concentration 0-24 hours
Serum testosterone was measured pre-dose and at 30 minutes, at 1 hour, 2, 4, 6, 8, 24, 48, and 72 hours after vaginal ring insertion, the transdermal application of the testosterone gel, or after taking DHEA capsules. The average serum concentration achieved in the first 24 hours after administration of the assigned treatment was calculated.
Time frame: Pre-dose and from 30 minutes after administration of the assigned treatment to 24 hours
DHEA: Average serum concentration 0-24 hours
Serum DHEA was measured pre-dose and at 30 minutes, at 1 hour, 2, 4, 6, 8, 24, 48, and 72 hours after vaginal ring insertion, the transdermal application of the testosterone gel, or after taking DHEA capsules. The average serum concentration achieved in the first 24 hours after administration of the assigned treatment was calculated.
Time frame: Pre-dose and from 30 minutes after administration of the assigned treatment to 24 hours
Testosterone: Maximum serum concentration (Cmax)
Serum testosterone was measured pre-dose and at 30 minutes, at 1 hour, 2, 4, 6, 8, 24, 48, and 72 hours after vaginal ring insertion, the transdermal application of the testosterone gel, or after taking DHEA capsules. Cmax was calculated.
Time frame: Pre-dose and from 30 minutes after administration of the assigned treatment to 72 hours
DHEA: Maximum serum concentration (Cmax)
Serum DHEA was measured pre-dose and at 30 minutes, at 1 hour, 2, 4, 6, 8, 24, 48, and 72 hours after vaginal ring insertion, the transdermal application of the testosterone gel, or after taking DHEA capsules. Cmax was calculated.
Time frame: Pre-dose and from 30 minutes after administration of the assigned treatment to 72 hours
Testosterone: Time to achieve maximum serum concentration (tmax)
Serum testosterone was measured pre-dose and at 30 minutes, at 1 hour, 2, 4, 6, 8, 24, 48, and 72 hours after vaginal ring insertion, the transdermal application of the testosterone gel, or after taking DHEA capsules. Tmax was calculated.
Time frame: pre-dose and from 30 minutes after administration of the assigned treatment to 72 hours
DHEA: Time to achieve maximum serum concentration (tmax)
Serum DHEA was measured pre-dose and at 30 minutes, at 1 hour, 2, 4, 6, 8, 24, 48, and 72 hours after vaginal ring insertion, the transdermal application of the testosterone gel, or after taking DHEA capsules. Tmax was calculated.
Time frame: pre-dose and from 30 minutes after administration of the assigned treatment to 72 hours

Study locations

1 site

Instituto de Investigación Materno Infantil (IDIMI) - Maternidad Hospital San Borja (HCSBA)
Santiago, Chile

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03967964
Lead sponsor: Laboratorios Andromaco S.A.
Responsible party: Sponsor
First posted: May 30, 2019
Start date: Nov 20, 2015
Primary completion: Jul 15, 2016
Completion: Jul 15, 2016
Last update: May 30, 2019

Study contacts

Grünenthal Study Director

study director · Grünenthal GmbH

View the source record on ClinicalTrials.gov ↗

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