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| Name | Class |
|---|---|
| Instituto Chileno de Medicina Reproductiva | OTHER |
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In this study, the investigators propose to assess if a non-hormonal agent is absorbed by a local route (vaginal) and to observe the effect on follicular development.
Each volunteer will participate for 3 menstrual cycles, beginning with one menstrual control cycle without treatment, following by one menstrual cycle with meloxicam ring administration, and finishing with another control menstrual cycle.
Meloxicam will be administered in the second menstrual cycle via a vaginal ring in two doses of 2.4 g or 3.0 g/ring. The safety of the vaginal ring and the absorption of meloxicam will be assessed. Also the effect on follicular development and if it maintains ovarian cyclicity, as shown in a recent study with oral administration, will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2.4 g Meloxicam Vaginal Ring | Experimental | Continuous wearing during one menstrual cycle (6 participants) |
|
| 3.0 g Meloxicam Vaginal Ring | Experimental | Continuous wearing during one menstrual cycle (6 participants) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meloxicam 2.4 g | Drug | 2.4 g in Vaginal Ring |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with follicular rupture delay | Evaluate effective dose of maximum local safety that causes a greater proportion of follicular rupture delays when it is administered continuously, starting on the day 5 +/- 1 of the cycle until next menses. | Participants will be followed for the duration of one menstrual cycle, an expected average of 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic of meloxicam via vaginal route: AUC | The AUC of meloxicam serum levels | An expected average of 28 days |
| Bleeding patterns with meloxicam vaginal ring | Women will complete a menstrual diary during their participation to evaluate the effects of treatment on the menstrual pattern. |
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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 Chileno de Medicina Reproductiva (ICMER) | Santiago | 8320165 | Chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19933235 | Background | Jesam C, Salvatierra AM, Schwartz JL, Croxatto HB. Suppression of follicular rupture with meloxicam, a cyclooxygenase-2 inhibitor: potential for emergency contraception. Hum Reprod. 2010 Feb;25(2):368-73. doi: 10.1093/humrep/dep392. Epub 2009 Nov 19. |
| Label | URL |
|---|---|
| Link to clinical site | View source |
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| ID | Term |
|---|---|
| D000077239 | Meloxicam |
| ID | Term |
|---|---|
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D013844 | Thiazoles |
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| Meloxicam 3.0 g |
| Drug |
3.0 g in Vaginal Ring |
|
| one menstrual cycle |
| Pharmacokinetic of meloxicam via vaginal route: Tmax | Tmax of meloxicam serum levels | An expected average of 28 days |
| Pharmacokinetic of meloxicam via vaginal route: Cmax | Cmax of meloxicam serum levels | An expected average of 28 days |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |