PharmacokineticsPhase 1NCT03967964
Pharmacokinetics of a Novel Vaginal Delivery System for Testosterone and Dehydroepiandrosterone (DHEA)
A Phase 1 study testing Dehydroepiandrosterone 2.2 g, Dehydroepiandrosterone 1.5 g/Testosterone 25 mg and Testosterone in people with Pharmacokinetics and Hormone Deficiency, run by Laboratorios Andromaco S.A. at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics, Hormone Deficiency
- What is being tested?
- Dehydroepiandrosterone 2.2 g, Dehydroepiandrosterone 1.5 g/Testosterone 25 mg and Testosterone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteChile
- Study dates
- 20 Nov 2015to 15 Jul 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Chile1 site
Instituto de Investigación Materno Infantil (IDIMI) - Maternidad Hospital San Borja (HCSBA)
Santiago
About this study
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
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
- Being tested
- Dehydroepiandrosterone 2.2 g, Dehydroepiandrosterone 1.5 g/Testosterone 25 mg, Testosterone, Testosterone Topical Gel, Dehydroepiandrosterone Oral Capsule
- Keywords
- Gynaecology, Obstetrics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dehydroepiandrosterone 2.2 gDrug
Vaginal ring with 2.2 grams DHEA.
Dehydroepiandrosterone 1.5 g/Testosterone 25 mgDrug
Vaginal ring with DHEA 1.5 grams/Testosterone 25 mg.
TestosteroneDrug
Vaginal ring with 35 mg testosterone.
Testosterone Topical GelDrug
Also called ActiserPump®
Gel containing 1% testosterone.
Dehydroepiandrosterone Oral CapsuleDrug
Capsule containing 25 mg DHEA
| Study group | Role | What they receive |
|---|---|---|
| Group 1: AVD | Experimental | Vaginal ring with 2.2 grams dehydroepiandrosterone (DHEA), wearing time 72 hours Receives: Drug: Dehydroepiandrosterone 2.2 g |
| Group 2: AVT | Experimental | Vaginal ring with 35 mg testosterone, wearing time 72 hours. Receives: Drug: Testosterone |
| Group 3: AVD+T | Experimental | Vaginal ring with 1.5 grams DHEA and 25 mg testosterone, wearing time 72 hours. Receives: Drug: Dehydroepiandrosterone 1.5 g/Testosterone 25 mg |
| Group 4: DHEA capsule | Active comparator | Capsules with 25 mg DHEA, oral administration every 8 hours for a 72-hour period. Receives: Drug: Dehydroepiandrosterone Oral Capsule |
| Group 5: Testosterone transdermal gel | Active comparator | 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). Receives: Drug: Testosterone Topical Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: pre-dose and from 30 minutes after administration of the assigned treatment to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start20 Nov 2015
- Primary completion15 Jul 2016
- Study completion15 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Andromaco S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Grünenthal Study Director, Study director, Grünenthal GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03967964
- Sponsor's protocol ID
- PKAVD+T
- Other IDs
- EC1503
- Status last verified
- May 2019
- First submitted
- 27 May 2019
- Last updated
- 30 May 2019
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03967964
- Acronym / sponsor ID
- PKAVD+T
- Conditions
- Pharmacokinetics, Hormone Deficiency
- Keywords
- Gynaecology, Obstetrics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Laboratorios Andromaco S.A.Industry (pharma, biotech, devices)
- Study start
- 20 Nov 2015 (actual)
- Primary completion
- 15 Jul 2016 (actual)
- Study completion
- 15 Jul 2016 (actual)
- First posted
- 30 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1: AVD | Experimental | Drug: Dehydroepiandrosterone 2.2 gVaginal ring with 2.2 grams dehydroepiandrosterone (DHEA), wearing time 72 hours |
| Group 2: AVT | Experimental | Drug: TestosteroneVaginal ring with 35 mg testosterone, wearing time 72 hours. |
| Group 3: AVD+T | Experimental | Drug: Dehydroepiandrosterone 1.5 g/Testosterone 25 mgVaginal ring with 1.5 grams DHEA and 25 mg testosterone, wearing time 72 hours. |
| Group 4: DHEA capsule | Active comparator | Drug: Dehydroepiandrosterone Oral CapsuleCapsules with 25 mg DHEA, oral administration every 8 hours for a 72-hour period. |
| Group 5: Testosterone transdermal gel | Active comparator | Drug: Testosterone Topical GelTestosterone 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). |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dehydroepiandrosterone 2.2 gVaginal ring with 2.2 grams DHEA. | Drug | Group 1: AVD |
| Dehydroepiandrosterone 1.5 g/Testosterone 25 mgVaginal ring with DHEA 1.5 grams/Testosterone 25 mg. | Drug | Group 3: AVD+T |
| TestosteroneVaginal ring with 35 mg testosterone. | Drug | Group 2: AVT |
| Testosterone Topical GelAlso: ActiserPump®Gel containing 1% testosterone. | Drug | Group 5: Testosterone transdermal gel |
| Dehydroepiandrosterone Oral CapsuleCapsule containing 25 mg DHEA | Drug | Group 4: DHEA capsule |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grünenthal Study Director study director
Grünenthal GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dehydroepiandrosterone 2.2 g, Dehydroepiandrosterone 1.5 g/Testosterone 25 mg and Testosterone in people with Pharmacokinetics and Hormone Deficiency, run by Laboratorios Andromaco S.A. at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2019.