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

NCT ID: NCT03967964

Last Updated: 2019-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-20
• Study Completion Date: 2016-07-15

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1: AVD

Vaginal ring with 2.2 grams dehydroepiandrosterone (DHEA), wearing time 72 hours

Group Type: EXPERIMENTAL

Dehydroepiandrosterone 2.2 g

Intervention Type: DRUG

Vaginal ring with 2.2 grams DHEA.

Group 2: AVT

Vaginal ring with 35 mg testosterone, wearing time 72 hours.

Group Type: EXPERIMENTAL

Testosterone

Intervention Type: DRUG

Vaginal ring with 35 mg testosterone.

Group 3: AVD+T

Vaginal ring with 1.5 grams DHEA and 25 mg testosterone, wearing time 72 hours.

Group Type: EXPERIMENTAL

Dehydroepiandrosterone 1.5 g/Testosterone 25 mg

Intervention Type: DRUG

Vaginal ring with DHEA 1.5 grams/Testosterone 25 mg.

Group 4: DHEA capsule

Capsules with 25 mg DHEA, oral administration every 8 hours for a 72-hour period.

Group Type: ACTIVE_COMPARATOR

Dehydroepiandrosterone Oral Capsule

Intervention Type: DRUG

Capsule containing 25 mg DHEA

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).

Group Type: ACTIVE_COMPARATOR

Testosterone Topical Gel

Intervention Type: DRUG

Gel containing 1% testosterone.

Interventions

Dehydroepiandrosterone 2.2 g

Vaginal ring with 2.2 grams DHEA.

Intervention Type: DRUG

Dehydroepiandrosterone 1.5 g/Testosterone 25 mg

Vaginal ring with DHEA 1.5 grams/Testosterone 25 mg.

Intervention Type: DRUG

Testosterone

Vaginal ring with 35 mg testosterone.

Intervention Type: DRUG

Testosterone Topical Gel

Gel containing 1% testosterone.

Intervention Type: DRUG

Dehydroepiandrosterone Oral Capsule

Capsule containing 25 mg DHEA

Intervention Type: DRUG

Other Intervention Names

ActiserPump®

Eligibility Criteria

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

• 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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Laboratorios Andromaco S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Grünenthal Study Director

Role: STUDY_DIRECTOR

Grünenthal GmbH

Locations

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

Santiago, , Chile

Countries

Chile

Other Identifiers

EC1503

Identifier Type: OTHER

Identifier Source: secondary_id

PKAVD+T

Identifier Type: -

Identifier Source: org_study_id