ContraceptionPhase 1NCT01839643
Assessment of a Vaginal Ring With Meloxicam on Ovarian Cycle in Fertile Women
A Phase 1 study testing Meloxicam 2.4 g and Meloxicam 3.0 g in people with Contraception and Bleeding Pattern, run by Laboratorios Andromaco S.A. at 1 site in Chile.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception, Bleeding Pattern
- What is being tested?
- Meloxicam 2.4 g and Meloxicam 3.0 g
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteChile
- Study dates
- 15 Jan 2013to 6 Jun 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Previous (or history of) proven fertility
- Regular menstrual cycle
- Surgically sterile
- Without breastfeeding
- Haemoglobin at least 11g/dL
- Willing to participate in the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Chile1 site
Instituto Chileno de Medicina Reproductiva (ICMER)
Santiago, 8320165
About this study
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
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.
Read the 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.
- Conditions
- Contraception, Bleeding Pattern
- Being tested
- Meloxicam 2.4 g, Meloxicam 3.0 g
- Keywords
- pharmacokinetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meloxicam 2.4 gDrug
2.4 g in Vaginal Ring
Meloxicam 3.0 gDrug
3.0 g in Vaginal Ring
| Study group | Role | What they receive |
|---|---|---|
| 2.4 g Meloxicam Vaginal Ring | Experimental | Continuous wearing during one menstrual cycle (6 participants) Receives: Drug: Meloxicam 2.4 g |
| 3.0 g Meloxicam Vaginal Ring | Experimental | Continuous wearing during one menstrual cycle (6 participants) Receives: Drug: Meloxicam 3.0 g |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Participants will be followed for the duration of one menstrual cycle, an expected average of 28 days
Secondary outcomes (4)
Pharmacokinetic of meloxicam via vaginal route: AUC
The AUC of meloxicam serum levels
Measured: 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.
Measured: one menstrual cycle
Pharmacokinetic of meloxicam via vaginal route: Tmax
Tmax of meloxicam serum levels
Measured: An expected average of 28 days
Pharmacokinetic of meloxicam via vaginal route: Cmax
Cmax of meloxicam serum levels
Measured: An expected average of 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2013 (estimated)
- Study start15 Jan 2013
- Primary completion7 May 2013
- Study completion6 Jun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Andromaco S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Instituto Chileno de Medicina Reproductiva
- Responsible party
- Sponsor
- Investigators
- Grünenthal Study Director, Study director, Grünenthal GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01839643
- Sponsor's protocol ID
- AVM-01001
- Status last verified
- Apr 2019
- First submitted
- 18 Mar 2013
- Last updated
- 30 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 19933235
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01839643
- Acronym / sponsor ID
- AVM-01001
- Conditions
- Contraception, Bleeding Pattern
- Keywords
- pharmacokinetic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Laboratorios Andromaco S.A.Industry (pharma, biotech, devices)
- Collaborators
- Instituto Chileno de Medicina Reproductiva
- Study start
- 15 Jan 2013 (actual)
- Primary completion
- 7 May 2013 (actual)
- Study completion
- 6 Jun 2013 (actual)
- First posted
- 25 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2.4 g Meloxicam Vaginal Ring | Experimental | Drug: Meloxicam 2.4 gContinuous wearing during one menstrual cycle (6 participants) |
| 3.0 g Meloxicam Vaginal Ring | Experimental | Drug: Meloxicam 3.0 gContinuous wearing during one menstrual cycle (6 participants) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Previous (or history of) proven fertility
- Regular menstrual cycle
- Surgically sterile
- Without breastfeeding
- Haemoglobin at least 11g/dL
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meloxicam 2.4 g2.4 g in Vaginal Ring | Drug | 2.4 g Meloxicam Vaginal Ring |
| Meloxicam 3.0 g3.0 g in Vaginal Ring | Drug | 3.0 g Meloxicam Vaginal Ring |
Primary outcome
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.
4 secondary outcomes
Pharmacokinetic of meloxicam via vaginal route: AUC
Time frame: An expected average of 28 days
Bleeding patterns with meloxicam vaginal ring
Time frame: one menstrual cycle
Pharmacokinetic of meloxicam via vaginal route: Tmax
Time frame: An expected average of 28 days
Pharmacokinetic of meloxicam via vaginal route: Cmax
Time frame: An expected average of 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2019.
- Background: PubMed 19933235Jesam 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.
- Link to clinical siteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grünenthal Study Director study director
Grünenthal GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Meloxicam 2.4 g and Meloxicam 3.0 g in people with Contraception and Bleeding Pattern, run by Laboratorios Andromaco S.A. at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01839643, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2019.