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A Comparative, Open-Label, Randomized, Parallel Group Study to determine Intraperitoneal fluids, tissue, and serum concentrations of VML-0501 following five days of daily vaginal applications of single dose of VML-0501 (100 mg Danazol), in comparison to five days of Danazol treatment administered as an oral capsule (Danatrol) at a daily dose of 600 mg, in two groups of twelve each consisting of women with suspected or confirmed endometriosis and scheduled for laparoscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Danatrol | Active Comparator | 200 mg orally TDS (600 mg daily) for 5-7 days |
|
| Vaginal Danazol | Experimental | 100 mg of Danazol Cream to be applied vaginally for 5-7 days on a single daily dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaginal Danazol | Drug | Proof of mechanism study to establish intraperitoneal and serum concentrations of Danazol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Danazol concentration | Concentration in serum and peritoneal fluid | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Danazol concentration | Concentration in endometrial tissue found outside the uterus | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Danazol concentration | Concentration in endometrium tissue | 6 months |
| Danazol concentration | Concentration in myometrium tissue | 6 months |
Inclusion Criteria:
Exclusion Criteria:
If any of the following criteria apply, the subject MUST NOT be admitted/continue the study trial.
The subject:
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| Name | Affiliation | Role |
|---|---|---|
| Simona Fiore, Dr | Viramal Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale L. Sacco - Milan-Obgyn Unit | Milan | 20157 | Italy |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 21, 2021 | |
| Reset | Oct 15, 2021 | |
| Release | Nov 16, 2021 |
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| Oral Danatrol | Drug | Proof of mechanism study to establish intraperitoneal and serum concentrations of Danazol |
|
| Reset | Dec 20, 2021 |
| Release | Mar 2, 2022 |
| Reset | May 19, 2022 |
| Release | May 20, 2022 |
| Reset | Feb 21, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 21, 2021 | Oct 15, 2021 | |||
| Nov 16, 2021 | Dec 20, 2021 | |||
| Mar 2, 2022 | May 19, 2022 | |||
| May 20, 2022 | Feb 21, 2023 |
| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D003613 | Danazol |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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