Contraception, PostcoitalPhase 2NCT01320709
Effect of Piroxicam on Ovulation
A Phase 2 study testing Piroxicam ( BAYl1902) in people with Contraception, Postcoital, run by Bayer at 1 site in Germany.
Trial summary
In this study the effect of piroxicam on the ovulation will be evaluated. Therefore piroxicam will be administered as a single-dose after onset of LH surge (luteinizing hormone, hormone which triggers ovulation). Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception, Postcoital
- What is being tested?
- Piroxicam ( BAYl1902)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2011to May 2012
- Phase
- Phase 2
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed informed consent available before any study specific tests or procedures are performed
- Healthy female subject
- Age: 18 to 35 years (inclusive) at the first screening visit
- Body mass index (BMI ): 18-30 kg/m² (inclusive) at the first screening visit
- Confirmation of the subject's health insurance coverage prior to the first screening visit
- Willingness to use non-hormonal methods of contraception during the study
- Ability to understand and follow study-related instructions
- Adequate venous access
Who cannot join
- Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination, and effects of the study drugs will not be normal
- Hypersensitivity to the active substance or skin reactions (irrespective of severity) to piroxicam, non-steroidal anti-inflammatory drugs or other medicinal products in the past
- History or presence of inflammatory diseases of the gastrointestinal tract, gastrointestinal bleeding, ulcers or perforation
- Regular intake of medication other than hormonal contraceptives
- Clinically relevant findings in the gynecological examination including transvaginal ultrasound (TVU)
- Clinically relevant findings in the physical examination, especially signs of bleeding diathesis or heart failure
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- Time point "onset of LH surge" in the pre-treatment cycle not determinable
- Time point "ovulation" in the pre-treatment cycle not determinable
- Lacking suitability for frequent TVU examinations
- History or presence of suffering from hay fever
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-center, Randomized, Placebo-controlled, Double-blind, Parallel Group Study to Evaluate Whether a Single-dose of Either 20 mg Piroxicam, 40 mg Piroxicam or 80 mg Piroxicam Shows an Effect on Ovulation After the Onset of LH Surge Compared to Placebo in Healthy Young Women
In this study the effect of piroxicam on the ovulation will be evaluated. Therefore piroxicam will be administered as a single-dose after onset of LH surge (luteinizing hormone, hormone which triggers ovulation).
Additionally blood levels of endogenous hormones (hormones produced by your body) will be measured and transvaginal ultrasound examinations will be conducted at regular intervals. In addition the concentration of piroxicam in blood will be determined in regular intervals.
With regards to the tolerability of the study drug subjects will be asked regularly how they feel.
- Conditions
- Contraception, Postcoital
- Being tested
- Piroxicam ( BAYl1902), Placebo
- Keywords
- Emergency contraception, Contraception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Piroxicam ( BAYl1902)Drug
Single dose of 20 mg piroxicam (i.e., 1 piroxicam capsule + 3 placebo capsule)
Piroxicam ( BAYl1902)Drug
Single dose of 40 mg piroxicam (i.e., 2 piroxicam capsules + 2 placebo capsule)
PlaceboDrug
Single dose of placebo (i.e., 4 placebo capsules)
Piroxicam ( BAYl1902)Drug
Single dose of 80 mg piroxicam (i.e., 4 piroxicam capsules)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Piroxicam ( BAYl1902) |
| Arm 2 | Experimental | Not described Receives: Drug: Piroxicam ( BAYl1902) |
| Arm 3 | Placebo comparator | Not described Receives: Drug: Placebo |
| Arm 4 | Experimental | Not described Receives: Drug: Piroxicam ( BAYl1902) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of piroxicam on ovulation (delay or inhibition) when given after the onset of LH surge
Measured: after 2 months
Secondary outcomes (3)
course of follicle sizes
Measured: after 2 months
course of gonadotropins (follicle-stimulating hormone [FSH], LH) and ovarian steroids (estradiol [E2], progesterone)
Measured: after 2 months
Concentration-times courses of piroxicam
Measured: after 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionMar 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contraception, PostcoitalStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01320709
- Sponsor's protocol ID
- 14835
- Other IDs
- 2010-021195-28
- Status last verified
- Dec 2014
- First submitted
- 21 Mar 2011
- Last updated
- 10 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center, Randomized, Placebo-controlled, Double-blind, Parallel Group Study to Evaluate Whether a Single-dose of Either 20 mg Piroxicam, 40 mg Piroxicam or 80 mg Piroxicam Shows an Effect on Ovulation After the Onset of LH Surge Compared to Placebo in Healthy Young Women
- ClinicalTrials.gov ID
- NCT01320709
- Acronym / sponsor ID
- 14835
- Conditions
- Contraception, Postcoital
- Keywords
- Emergency contraception, Contraception
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 22 Mar 2011 (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 effect of piroxicam on the ovulation will be evaluated. Therefore piroxicam will be administered as a single-dose after onset of LH surge (luteinizing hormone, hormone which triggers ovulation).
Additionally blood levels of endogenous hormones (hormones produced by your body) will be measured and transvaginal ultrasound examinations will be conducted at regular intervals. In addition the concentration of piroxicam in blood will be determined in regular intervals.
With regards to the tolerability of the study drug subjects will be asked regularly how they feel.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Piroxicam ( BAYl1902) |
| Arm 2 | Experimental | Drug: Piroxicam ( BAYl1902) |
| Arm 3 | Placebo comparator | Drug: Placebo |
| Arm 4 | Experimental | Drug: Piroxicam ( BAYl1902) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Signed informed consent available before any study specific tests or procedures are performed
- Healthy female subject
- Age: 18 to 35 years (inclusive) at the first screening visit
- Body mass index (BMI ): 18-30 kg/m² (inclusive) at the first screening visit
- Confirmation of the subject's health insurance coverage prior to the first screening visit
Key exclusion criteria (10 listed)
- Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination, and effects of the study drugs will not be normal
- Hypersensitivity to the active substance or skin reactions (irrespective of severity) to piroxicam, non-steroidal anti-inflammatory drugs or other medicinal products in the past
- History or presence of inflammatory diseases of the gastrointestinal tract, gastrointestinal bleeding, ulcers or perforation
- Regular intake of medication other than hormonal contraceptives
- Clinically relevant findings in the gynecological examination including transvaginal ultrasound (TVU)
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 |
|---|---|---|
| Piroxicam ( BAYl1902)Single dose of 20 mg piroxicam (i.e., 1 piroxicam capsule + 3 placebo capsule) | Drug | Arm 1 |
| Piroxicam ( BAYl1902)Single dose of 40 mg piroxicam (i.e., 2 piroxicam capsules + 2 placebo capsule) | Drug | Arm 2 |
| PlaceboSingle dose of placebo (i.e., 4 placebo capsules) | Drug | Arm 3 |
| Piroxicam ( BAYl1902)Single dose of 80 mg piroxicam (i.e., 4 piroxicam capsules) | Drug | Arm 4 |
Primary outcome
Effect of piroxicam on ovulation (delay or inhibition) when given after the onset of LH surge
Time frame: after 2 months
3 secondary outcomes
course of follicle sizes
Time frame: after 2 months
course of gonadotropins (follicle-stimulating hormone [FSH], LH) and ovarian steroids (estradiol [E2], progesterone)
Time frame: after 2 months
Concentration-times courses of piroxicam
Time frame: after 2 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 10 Jul 2015.
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.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Piroxicam ( BAYl1902) in people with Contraception, Postcoital, run by Bayer at 1 site in Germany.
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 8 inclusion and 10 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 10 Jul 2015. 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 Germany. 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 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.
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?
Effect of piroxicam on ovulation (delay or inhibition) when given after the onset of LH surge (time frame: after 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jul 2015.