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Trial record 71 of 236 for:    PRASTERONE

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

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ClinicalTrials.gov Identifier: NCT03967964
Recruitment Status : Completed
First Posted : May 30, 2019
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
Laboratorios Andromaco S.A.

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.

Condition or disease Intervention/treatment Phase
Pharmacokinetics Hormone Deficiency Drug: Dehydroepiandrosterone 2.2 g Drug: Dehydroepiandrosterone 1.5 g/Testosterone 25 mg Drug: Testosterone Drug: Testosterone Topical Gel Drug: Dehydroepiandrosterone Oral Capsule Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a prospective, randomized, open-label comparative, single-site study with 5 treatment groups. Each participant receives a single Treatment for 72 hours. Allocation to Treatment is in a 1:1:1:1:1 order.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 20, 2015
Actual Primary Completion Date : July 15, 2016
Actual Study Completion Date : July 15, 2016

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Arm Intervention/treatment
Experimental: Group 1: AVD
Vaginal ring with 2.2 grams dehydroepiandrosterone (DHEA), wearing time 72 hours
Drug: Dehydroepiandrosterone 2.2 g
Vaginal ring with 2.2 grams DHEA.

Experimental: Group 2: AVT
Vaginal ring with 35 mg testosterone, wearing time 72 hours.
Drug: Testosterone
Vaginal ring with 35 mg 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
Vaginal ring with DHEA 1.5 grams/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
Capsule containing 25 mg DHEA

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
Gel containing 1% testosterone.
Other Name: ActiserPump®




Primary Outcome Measures :
  1. Testosterone: Area under the serum concentration time curve (AUC0-72) [ Time Frame: Pre-dose and from 30 minutes after administration of the assigned treatment to 72 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 AUC0-72 was calculated.

  2. DHEA: Area under the serum concentration time curve (AUC0-72) [ Time Frame: Pre-dose and from 30 minutes after administration of the assigned treatment to 72 hours ]
    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.

  3. Testosterone: Average serum concentration 0-24 hours [ Time Frame: Pre-dose and from 30 minutes after administration of the assigned treatment to 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.

  4. DHEA: Average serum concentration 0-24 hours [ Time Frame: Pre-dose and from 30 minutes after administration of the assigned treatment to 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.

  5. Testosterone: Maximum serum concentration (Cmax) [ Time Frame: Pre-dose and from 30 minutes after administration of the assigned treatment to 72 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. Cmax was calculated.

  6. DHEA: Maximum serum concentration (Cmax) [ Time Frame: Pre-dose and from 30 minutes after administration of the assigned treatment to 72 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. Cmax was calculated.

  7. Testosterone: Time to achieve maximum serum concentration (tmax) [ Time Frame: pre-dose and from 30 minutes after administration of the assigned treatment to 72 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. Tmax was calculated.

  8. DHEA: Time to achieve maximum serum concentration (tmax) [ Time Frame: pre-dose and from 30 minutes after administration of the assigned treatment to 72 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. Tmax was calculated.



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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03967964


Locations
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Chile
Instituto de Investigación Materno Infantil (IDIMI) - Maternidad Hospital San Borja (HCSBA)
Santiago, Chile
Sponsors and Collaborators
Laboratorios Andromaco S.A.
Investigators
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Study Director: Grünenthal Study Director Grünenthal GmbH

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Responsible Party: Laboratorios Andromaco S.A.
ClinicalTrials.gov Identifier: NCT03967964     History of Changes
Other Study ID Numbers: PKAVD+T
EC1503 ( Other Identifier: Sponsor code )
First Posted: May 30, 2019    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Laboratorios Andromaco S.A.:
Gynaecology
Obstetrics
Additional relevant MeSH terms:
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Dehydroepiandrosterone
Methyltestosterone
Testosterone
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents
Adjuvants, Immunologic
Immunologic Factors