Assessment of a Vaginal Ring With Meloxicam on Ovarian Cycle in Fertile Women

Contraception Clinical Trial

Official title:

Phase 1 Study of Assessment of Local Absorption of a Non-steroidal Antiinflammatory Drug (NSAID), Inhibitor of Cyclooxygenase 2 (COX-2) Meloxicam, Through a Vaginal Ring and Its Effect on Ovarian Cycle in Fertile Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01839643
• Other study ID #: AVM-01001
• Status: Completed
• Phase: Phase 1
• Start date: January 15, 2013
• Est. completion date: June 6, 2013

Study information

• Verified date: April 2019
• Source: Laboratorios Andromaco S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: June 6, 2013
• Est. primary completion date: May 7, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Previous (or history of) proven fertility

• Regular menstrual cycle

• Surgically sterile

• Without breastfeeding

• Haemoglobin at least 11g/dL

• Willing to participate in the study

Exclusion Criteria:

• Allergy to meloxicam or other NSAID

• Allergy to silicone polymer

• Vaginal discharge non diagnosticated

• History of shock toxic syndrome

• History of : gastrointestinal, bleeding, renal, liver, heart, brain,clot, endocrine or pulmonary disorders

Related Conditions & MeSH terms

• Bleeding Pattern
• Contraception

Intervention

Drug:
• Meloxicam 2.4 g
2.4 g in Vaginal Ring
• Meloxicam 3.0 g
3.0 g in Vaginal Ring

Locations

Country	Name	City	State
Chile	Instituto Chileno de Medicina Reproductiva (ICMER)	Santiago

Sponsors (2)

Lead Sponsor	Collaborator
Laboratorios Andromaco S.A.	Instituto Chileno de Medicina Reproductiva

Country where clinical trial is conducted

Chile, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Pharmacokinetic of meloxicam via vaginal route: AUC	The AUC of meloxicam serum levels	An expected average of 28 days
Secondary	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.	one menstrual cycle
Secondary	Pharmacokinetic of meloxicam via vaginal route: Tmax	Tmax of meloxicam serum levels	An expected average of 28 days
Secondary	Pharmacokinetic of meloxicam via vaginal route: Cmax	Cmax of meloxicam serum levels	An expected average of 28 days

External Links

•   Link to clinical site