Skip to main content
OpenTrials
Completed

NCT Number: NCT01839643

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Contraception Bleeding Pattern

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Instituto Chileno de Medicina Reproductiva (ICMER)

Santiago, 8320165, Chile

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Meloxicam 2.4 g

Drug

2.4 g in Vaginal Ring

Meloxicam 3.0 g

Drug

3.0 g in Vaginal Ring

Primary outcomes

  1. Number of participants with follicular rupture delay

    Time frame: 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 outcomes

  1. Pharmacokinetic of meloxicam via vaginal route: AUC

    Time frame: An expected average of 28 days

    The AUC of meloxicam serum levels

  2. Bleeding patterns with meloxicam vaginal ring

    Time frame: 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

    Time frame: An expected average of 28 days

    Tmax of meloxicam serum levels

  4. Pharmacokinetic of meloxicam via vaginal route: Cmax

    Time frame: An expected average of 28 days

    Cmax of meloxicam serum levels

Sponsors and collaborators

Lead sponsor

Laboratorios Andromaco S.A.

Industry

Collaborators

  • Instituto Chileno de Medicina Reproductiva

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Apr 25, 2013
Registry last updated
Apr 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.