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

Sponsor
Laboratorios Andromaco S.A. (Industry)
Overall Status
Completed
CT.gov ID
NCT01839643
Collaborator
Instituto Chileno de Medicina Reproductiva (Other)
13
Enrollment
1
Location
2
Arms
4.7
Actual Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Meloxicam 2.4 g
  • Drug: Meloxicam 3.0 g
 Phase 1

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
13 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Diagnostic
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
Actual Study Start Date :
Jan 15, 2013
Actual Primary Completion Date :
May 7, 2013
Actual Study Completion Date :
Jun 6, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: 2.4 g Meloxicam Vaginal Ring

Continuous wearing during one menstrual cycle (6 participants)

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

Continuous wearing during one menstrual cycle (6 participants)

Drug: Meloxicam 3.0 g
3.0 g in Vaginal Ring

Outcome Measures

Primary Outcome Measures

  1. Number of participants with follicular rupture delay [Participants will be followed for the duration of one menstrual cycle, an expected average of 28 days]

    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.

Secondary Outcome Measures

  1. Pharmacokinetic of meloxicam via vaginal route: AUC [An expected average of 28 days]

    The AUC of meloxicam serum levels

  2. Bleeding patterns with meloxicam vaginal ring [one menstrual cycle]

    Women will complete a menstrual diary during their participation to evaluate the effects of treatment on the menstrual pattern.

  3. Pharmacokinetic of meloxicam via vaginal route: Tmax [An expected average of 28 days]

    Tmax of meloxicam serum levels

  4. Pharmacokinetic of meloxicam via vaginal route: Cmax [An expected average of 28 days]

    Cmax of meloxicam serum levels

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Instituto Chileno de Medicina Reproductiva (ICMER) Santiago Chile 8320165

Sponsors and Collaborators

  • Laboratorios Andromaco S.A.
  • Instituto Chileno de Medicina Reproductiva

Investigators

  • Study Director: Grünenthal Study Director, Grünenthal GmbH

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Laboratorios Andromaco S.A.
ClinicalTrials.gov Identifier:
NCT01839643
Other Study ID Numbers:
  • AVM-01001
First Posted:
Apr 25, 2013
Last Update Posted:
Apr 30, 2019
Last Verified:
Apr 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Laboratorios Andromaco S.A.
pharmacokinetic
Additional relevant MeSH terms:
Meloxicam

Study Results

No Results Posted as of Apr 30, 2019