| 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 |
| 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 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Group 1: AVD
Vaginal ring with 2.2 grams dehydroepiandrosterone (DHEA), wearing time 72 hours
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Drug: Dehydroepiandrosterone 2.2 g
Vaginal ring with 2.2 grams DHEA.
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Experimental: Group 2: AVT
Vaginal ring with 35 mg testosterone, wearing time 72 hours.
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Drug: Testosterone
Vaginal ring with 35 mg testosterone.
|
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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.
|
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Active Comparator: Group 4: DHEA capsule
Capsules with 25 mg DHEA, oral administration every 8 hours for a 72-hour period.
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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®
|
| Ages Eligible for Study: | 40 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
| Chile | |
| Instituto de Investigación Materno Infantil (IDIMI) - Maternidad Hospital San Borja (HCSBA) | |
| Santiago, Chile | |
| Study Director: | Grünenthal Study Director | Grünenthal GmbH |
| Tracking Information | ||||
|---|---|---|---|---|
| First Submitted Date ICMJE | May 27, 2019 | |||
| First Posted Date ICMJE | May 30, 2019 | |||
| Last Update Posted Date | May 30, 2019 | |||
| Actual Study Start Date ICMJE | November 20, 2015 | |||
| Actual Primary Completion Date | July 15, 2016 (Final data collection date for primary outcome measure) | |||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | |||
| Change History | No Changes Posted | |||
| Current Secondary Outcome Measures ICMJE | Not Provided | |||
| Original Secondary Outcome Measures ICMJE | Not Provided | |||
| Current Other Pre-specified Outcome Measures | Not Provided | |||
| Original Other Pre-specified Outcome Measures | Not Provided | |||
| Descriptive Information | ||||
| Brief Title ICMJE | Pharmacokinetics of a Novel Vaginal Delivery System for Testosterone and Dehydroepiandrosterone (DHEA) | |||
| Official Title ICMJE | 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 | |||
| 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. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 1 | |||
| Study Design ICMJE | 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 |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | |||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE |
46 | |||
| Original Actual Enrollment ICMJE | Same as current | |||
| Actual Study Completion Date ICMJE | July 15, 2016 | |||
| Actual Primary Completion Date | July 15, 2016 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 40 Years to 60 Years (Adult) | |||
| Accepts Healthy Volunteers ICMJE | Yes | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Chile | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT03967964 | |||
| Other Study ID Numbers ICMJE | PKAVD+T EC1503 ( Other Identifier: Sponsor code ) |
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| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE |
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| Responsible Party | Laboratorios Andromaco S.A. | |||
| Study Sponsor ICMJE | Laboratorios Andromaco S.A. | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
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| PRS Account | Laboratorios Andromaco S.A. | |||
| Verification Date | May 2019 | |||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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