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| ID | Type | Description | Link |
|---|---|---|---|
| EC1503 | Other Identifier | Sponsor code |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: AVD | Experimental | Vaginal ring with 2.2 grams dehydroepiandrosterone (DHEA), wearing time 72 hours |
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| Group 2: AVT | Experimental | Vaginal ring with 35 mg testosterone, wearing time 72 hours. |
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| Group 3: AVD+T | Experimental | Vaginal ring with 1.5 grams DHEA and 25 mg testosterone, wearing time 72 hours. |
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| Group 4: DHEA capsule | Active Comparator | Capsules with 25 mg DHEA, oral administration every 8 hours for a 72-hour period. |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dehydroepiandrosterone 2.2 g | Drug | Vaginal ring with 2.2 grams DHEA. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | Pre-dose and from 30 minutes after administration of the assigned treatment to 24 hours |
| Testosterone: Maximum serum concentration (Cmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Grünenthal Study Director | Grünenthal GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Investigación Materno Infantil (IDIMI) - Maternidad Hospital San Borja (HCSBA) | Santiago | Chile |
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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.
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| Dehydroepiandrosterone 1.5 g/Testosterone 25 mg |
| Drug |
Vaginal ring with DHEA 1.5 grams/Testosterone 25 mg. |
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| Testosterone | Drug | Vaginal ring with 35 mg testosterone. |
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| Testosterone Topical Gel | Drug | Gel containing 1% testosterone. |
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| Dehydroepiandrosterone Oral Capsule | Drug | Capsule containing 25 mg DHEA |
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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. |
| 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. | 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. | 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. | pre-dose and from 30 minutes after administration of the assigned treatment to 72 hours |
| ID | Term |
|---|---|
| D003687 | Dehydroepiandrosterone |
| D013739 | Testosterone |
| ID | Term |
|---|---|
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D015068 | 17-Ketosteroids |
| D007664 | Ketosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
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