DysmenorrheaPhase 2/3NCT02255045
Assessment of a Vaginal Ring With Meloxicam in the Treatment of Dysmenorrhea
A Phase 2/3 study testing Meloxicam and Diclofenac Potassium in people with Dysmenorrhea, run by Laboratorios Andromaco S.A. at 1 site in Chile.
Trial summary
The investigators propose that the sustained administration of a vaginal ring would have a better response with respect to pain and a better safety profile than the oral administration of a non-steroidal anti-inflammatory drug. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dysmenorrhea
- What is being tested?
- Meloxicam and Diclofenac Potassium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteChile
- Study dates
- 27 Jun 2014to 16 Mar 2016
- Phase
- Phase 2/3
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Regular menstrual cycles on previous 3 months (24-35 days),
- Primary dysmenorrhea on 3 previous months,
- With tubal ligation or users of condom for contraception,
- Hemoglobin of at least 11 g/dl,
- Safety blood analysis in normal levels
Who cannot join
- Secondary dysmenorrhea,
- Users of hormonal contraceptives (2 months prior to the study) or intrauterine devices (IUDs) (1 month prior the study).
- Allergy to any anti-inflammatory drug including meloxicam or diclofenac.
- Allergy to silicon.
- Pregnant or in lactation.
- Women with untreated or decompensated endocrine 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: Evaluation of the Effect of a Vaginal Ring With Meloxicam on Primary Dysmenorrhea in Women of Childbearing Age
The investigators propose that the sustained administration of a vaginal ring would have a better response with respect to pain and a better safety profile than the oral administration of a non-steroidal anti-inflammatory drug.
To assess the relief of the symptoms associated with dysmenorrhea, a specific survey was elaborated that also includes a Visual Analog Scale (VAS) to objectify and measure dysmenorrhea as is the case with McGill's Pain Questionnaire (MPQ).
- Conditions
- Dysmenorrhea
- Being tested
- Meloxicam, Diclofenac Potassium, Placebo Oral, Placebo Vaginal
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeloxicamDrug
1 Meloxicam Vaginal Ring (MVR) for 4-6 days
Diclofenac PotassiumDrug
1 tablet 50 mg diclofenac every 12 hours for 4-6 days
Placebo OralDrug
1 placebo tablet every 12 hours for 4-6 days
Placebo VaginalDrug
1 placebo vaginal ring for 4-6 days
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 of meloxicam in vaginal ring | Experimental | 2.4 g of meloxicam in a vaginal ring Receives: Drug: Meloxicam; Drug: Placebo Oral |
| Dose 2 of meloxicam in vaginal ring | Experimental | 3.0 g of meloxicam in a vaginal ring Receives: Drug: Meloxicam; Drug: Placebo Oral |
| Oral non-steroidal anti-inflammatory drug | Active comparator | Diclofenac potassium Receives: Drug: Diclofenac Potassium; Drug: Placebo Vaginal |
| Placebo vaginal ring and oral pill | Placebo comparator | Placebo vaginal ring and placebo oral pill Receives: Drug: Placebo Oral; Drug: Placebo Vaginal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Percentage of primary dysmenorrhea reduction
Change in primary dysmenorrhea using the VAS (0 = pain-free, 10 = maximum pain intensity) for the vaginal ring with meloxicam used during the perimenstrual period compared with a placebo ring.
Measured: 5 months
Secondary outcomes (2)
Minimum effective dose of meloxicam
Determine the minimum effective dose of the vaginal ring with meloxicam in primary dysmenorrhea using a survey. This survey includes a VAS (0 = pain-free, 10 = maximum pain intensity) to evaluate pain intensity, questions about the pain type (superficial, deep), pain location (diffuse, localized), pain duration (for a moment, intermittent, constant), location in the abdominal or back region (yes/no), and the presence of breast pain, thigh pain, mood changes, mastalgia, gastrointestinal disorders, abdominal distension, headache, dizziness, or acne (all with yes/no responses). Furthermore, the survey includes quality of life assessments (effects on routine activity, on work activity and/or housework, social and recreational activities, family and/or interpersonal relationships, state of mind, and sleep quality: 0 = no negative effect, 10 = maximum negative effect).
Measured: 5 months
Efficacy: Comparison of meloxicam vaginal ring and oral diclofenac
Compare the effect of a vaginal ring with meloxicam versus the oral administration of a non-steroidal anti-inflammatory drug commonly used for primary dysmenorrhea during one menstrual cycle, using a survey. This survey includes a VAS (0 = pain-free, 10 = maximum pain intensity) to evaluate pain intensity, questions about the pain type (superficial, deep), pain location (diffuse, localized), pain duration (for a moment, intermittent, constant), location in the abdominal or back region (yes/no), and the presence of breast pain, thigh pain, mood changes, mastalgia, gastrointestinal disorders, abdominal distension, headache, dizziness, or acne (all with yes/no responses). Furthermore, the survey includes quality of life assessments (effects on routine activity, on work activity and/or housework, social and recreational activities, family and/or interpersonal relationships, state of mind, and sleep quality: 0 = no negative effect, 10 = maximum negative effect).
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2014 (estimated)
- Study start27 Jun 2014
- Primary completion21 Feb 2016
- Study completion16 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DysmenorrheaStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Andromaco S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Grünenthal Study Director, Study director, Grünenthal GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02255045
- Sponsor's protocol ID
- AVM002
- Status last verified
- May 2019
- First submitted
- 22 Sep 2014
- Last updated
- 3 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Marjoribanks J, Proctor M, Farquhar C, Derks RS. Nonsteroidal anti-inflammatory drugs for dysmenorrhoea. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD001751. doi: 10.1002/14651858.CD001751.pub2.
PubMed 20091521Harel Z. Cyclooxygenase-2 specific inhibitors in the treatment of dysmenorrhea. J Pediatr Adolesc Gynecol. 2004 Apr;17(2):75-9. doi: 10.1016/j.jpag.2004.01.002.
PubMed 15050982de Mello NR, Baracat EC, Tomaz G, Bedone AJ, Camargos A, Barbosa IC, de Souza RN, Rumi DO, Martinez Alcala FO, Velasco JA, Cortes RJ. Double-blind study to evaluate efficacy and safety of meloxicam 7.5 mg and 15 mg versus mefenamic acid 1500 mg in the treatment of primary dysmenorrhea. Acta Obstet Gynecol Scand. 2004 Jul;83(7):667-73. doi: 10.1111/j.0001-6349.2004.00433.x.
PubMed 15225193Chantler I, Mitchell D, Fuller A. The effect of three cyclo-oxygenase inhibitors on intensity of primary dysmenorrheic pain. Clin J Pain. 2008 Jan;24(1):39-44. doi: 10.1097/AJP.0b013e318156dafc.
PubMed 18180635
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of a Vaginal Ring With Meloxicam on Primary Dysmenorrhea in Women of Childbearing Age
- ClinicalTrials.gov ID
- NCT02255045
- Acronym / sponsor ID
- AVM002
- Conditions
- Dysmenorrhea
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Laboratorios Andromaco S.A.Industry (pharma, biotech, devices)
- Study start
- 27 Jun 2014 (actual)
- Primary completion
- 21 Feb 2016 (actual)
- Study completion
- 16 Mar 2016 (actual)
- First posted
- 2 Oct 2014 (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.
The investigators propose that the sustained administration of a vaginal ring would have a better response with respect to pain and a better safety profile than the oral administration of a non-steroidal anti-inflammatory drug.
To assess the relief of the symptoms associated with dysmenorrhea, a specific survey was elaborated that also includes a Visual Analog Scale (VAS) to objectify and measure dysmenorrhea as is the case with McGill's Pain Questionnaire (MPQ).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose 1 of meloxicam in vaginal ring | Experimental | Drug: Meloxicam, Drug: Placebo Oral2.4 g of meloxicam in a vaginal ring |
| Dose 2 of meloxicam in vaginal ring | Experimental | Drug: Meloxicam, Drug: Placebo Oral3.0 g of meloxicam in a vaginal ring |
| Oral non-steroidal anti-inflammatory drug | Active comparator | Drug: Diclofenac Potassium, Drug: Placebo VaginalDiclofenac potassium |
| Placebo vaginal ring and oral pill | Placebo comparator | Drug: Placebo Oral, Drug: Placebo VaginalPlacebo vaginal ring and placebo oral pill |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Regular menstrual cycles on previous 3 months (24-35 days),
- Primary dysmenorrhea on 3 previous months,
- With tubal ligation or users of condom for contraception,
- Hemoglobin of at least 11 g/dl,
- Safety blood analysis in normal levels
Key exclusion criteria (6 listed)
- Secondary dysmenorrhea,
- Users of hormonal contraceptives (2 months prior to the study) or intrauterine devices (IUDs) (1 month prior the study).
- Allergy to any anti-inflammatory drug including meloxicam or diclofenac.
- Allergy to silicon.
- Pregnant or in lactation.
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 |
|---|---|---|
| Meloxicam1 Meloxicam Vaginal Ring (MVR) for 4-6 days | Drug | Dose 1 of meloxicam in vaginal ring, Dose 2 of meloxicam in vaginal ring |
| Diclofenac Potassium1 tablet 50 mg diclofenac every 12 hours for 4-6 days | Drug | Oral non-steroidal anti-inflammatory drug |
| Placebo Oral1 placebo tablet every 12 hours for 4-6 days | Drug | Dose 1 of meloxicam in vaginal ring, Dose 2 of meloxicam in vaginal ring, Placebo vaginal ring and oral pill |
| Placebo Vaginal1 placebo vaginal ring for 4-6 days | Drug | Oral non-steroidal anti-inflammatory drug, Placebo vaginal ring and oral pill |
Primary outcome
Efficacy: Percentage of primary dysmenorrhea reduction
Time frame: 5 months
Change in primary dysmenorrhea using the VAS (0 = pain-free, 10 = maximum pain intensity) for the vaginal ring with meloxicam used during the perimenstrual period compared with a placebo ring.
2 secondary outcomes
Minimum effective dose of meloxicam
Time frame: 5 months
Efficacy: Comparison of meloxicam vaginal ring and oral diclofenac
Time frame: 5 months
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 3 May 2019.
- Background: PubMed 20091521Marjoribanks J, Proctor M, Farquhar C, Derks RS. Nonsteroidal anti-inflammatory drugs for dysmenorrhoea. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD001751. doi: 10.1002/14651858.CD001751.pub2.
- Background: PubMed 15050982Harel Z. Cyclooxygenase-2 specific inhibitors in the treatment of dysmenorrhea. J Pediatr Adolesc Gynecol. 2004 Apr;17(2):75-9. doi: 10.1016/j.jpag.2004.01.002.
- Background: PubMed 15225193de Mello NR, Baracat EC, Tomaz G, Bedone AJ, Camargos A, Barbosa IC, de Souza RN, Rumi DO, Martinez Alcala FO, Velasco JA, Cortes RJ. Double-blind study to evaluate efficacy and safety of meloxicam 7.5 mg and 15 mg versus mefenamic acid 1500 mg in the treatment of primary dysmenorrhea. Acta Obstet Gynecol Scand. 2004 Jul;83(7):667-73. doi: 10.1111/j.0001-6349.2004.00433.x.
- Background: PubMed 18180635Chantler I, Mitchell D, Fuller A. The effect of three cyclo-oxygenase inhibitors on intensity of primary dysmenorrheic pain. Clin J Pain. 2008 Jan;24(1):39-44. doi: 10.1097/AJP.0b013e318156dafc.
- 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 2/3 study testing Meloxicam and Diclofenac Potassium in people with Dysmenorrhea, 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 5 inclusion and 6 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 3 May 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Efficacy: Percentage of primary dysmenorrhea reduction (time frame: 5 months). 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 NCT02255045, which also lists 4 linked publications.
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 3 May 2019.