DysmenorrheaPhase 3NCT00212342
Efficacy and Safety Study of Low Dose Oral Contraceptive Pill to Treat Dysmenorrhea
A Phase 3 study testing Norethisterone,Ethinylestradiol and Sugar pill in people with Dysmenorrhea, run by Nobelpharma.
Trial summary
The purpose of this study is to determine whether combination oral contraceptive pill of Norethindrone \& Ethinyl estradiol is effective in the treatment of dysmenorrhea associated with endometriosis. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Dysmenorrhea
- What is being tested?
- Norethisterone,Ethinylestradiol and Sugar pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 2004to Mar 2006
- Phase
- Phase 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- dysmenorrhea associated with endometriosis
Who cannot join
- severe hepatopathy
- pregnant woman
About this study
Official title: Phase 3,Placebo Controlled,Randomized,Double-Blinded,NSAID-Add-on,Clinical Trial of Mono-phase Low Dose Oral Contraceptive Pill for Treatment of Dysmenorrhea Associated With Endometriosis.
The purpose of this study is to determine whether combination oral contraceptive pill of Norethindrone \& Ethinyl estradiol is effective in the treatment of dysmenorrhea associated with endometriosis.
- Conditions
- Dysmenorrhea
- Being tested
- Norethisterone,Ethinylestradiol, Sugar pill
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Norethisterone,EthinylestradiolDrug
Sugar pillDrug
| Study group | Role | What they receive |
|---|---|---|
| Norethisterone,Ethinylestradiol | Experimental | Not described Receives: Drug: Norethisterone,Ethinylestradiol |
| Sugar pill | Placebo comparator | Not described Receives: Drug: Sugar pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient response to treatment for dysmenorrhea associated with endometriosis,as evaluated by VRS
Secondary outcomes (5)
changes in the VAS of dysmenorrhea.
changes in the VRS of non-menstrual pain.
changes in the VAS of non-menstrual pain.
changes in the clinical evaluation of pelvic induration.
changes in the size of ovarian endometrioma.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startDec 2004
- Primary completionJan 2006
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nobelpharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Naoki Terakawa, M.D.,Ph.D., Study director, Tottori University,Tottori,Japan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00212342
- Sponsor's protocol ID
- IKH-01-4
- Status last verified
- Sep 2010
- First submitted
- 13 Sep 2005
- Last updated
- 8 Sep 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3,Placebo Controlled,Randomized,Double-Blinded,NSAID-Add-on,Clinical Trial of Mono-phase Low Dose Oral Contraceptive Pill for Treatment of Dysmenorrhea Associated With Endometriosis.
- ClinicalTrials.gov ID
- NCT00212342
- Acronym / sponsor ID
- IKH-01-4
- Conditions
- Dysmenorrhea
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- NobelpharmaIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Primary completion
- Jan 2006 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 21 Sep 2005 (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 purpose of this study is to determine whether combination oral contraceptive pill of Norethindrone \& Ethinyl estradiol is effective in the treatment of dysmenorrhea associated with endometriosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Norethisterone,Ethinylestradiol | Experimental | Drug: Norethisterone,Ethinylestradiol |
| Sugar pill | Placebo comparator | Drug: Sugar pill |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- dysmenorrhea associated with endometriosis
Key exclusion criteria (2 listed)
- severe hepatopathy
- pregnant woman
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 |
|---|---|---|
| Norethisterone,Ethinylestradiol | Drug | Norethisterone,Ethinylestradiol |
| Sugar pill | Drug | Sugar pill |
Primary outcome
patient response to treatment for dysmenorrhea associated with endometriosis,as evaluated by VRS
5 secondary outcomes
changes in the VAS of dysmenorrhea.
changes in the VRS of non-menstrual pain.
changes in the VAS of non-menstrual pain.
changes in the clinical evaluation of pelvic induration.
changes in the size of ovarian endometrioma.
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 8 Sep 2010.
Related trials for Dysmenorrhea
Not yet recruiting
Radiofrequency and Pelvic Floor Exercise for Primary Dysmenorrhea
Primary Dysmenorrhea
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
Not yet recruiting
Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis
Adenomyosis, Adenomyoma of Uterus
Active, not recruiting
Mindfulness-Based Education For Women With Polycystic Ovary Syndrome
Polycystic Ovary Syndrome (PCOS), Menstrual Symptoms
Not yet recruiting
The Effect of a Ginger Formula on Menstrual Health vs a Placebo
Painful Menstruation
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.
Naoki Terakawa, M.D.,Ph.D. study director
Tottori University,Tottori,Japan
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Norethisterone,Ethinylestradiol and Sugar pill in people with Dysmenorrhea, run by Nobelpharma.
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 1 inclusion and 2 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 8 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
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 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?
patient response to treatment for dysmenorrhea associated with endometriosis,as evaluated by VRS. 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 8 Sep 2010.