DysmenorrheaPhase 4NCT02237131
Continuous Versus Cyclic Oral Contraceptives for Endometriosis
A Phase 4 study testing Oral contraceptives cyclic and Oral contraceptives continuous in people with Dysmenorrhea and Pelvic Pain, run by University of Athens at 1 site in Greece.
Trial summary
To evaluate the efficacy of oral contraceptives in a continuous fashion versus the usual cyclic fashion in the recurrence of endometriosis related symptoms and endometriomas following fertility-sparing surgery. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Dysmenorrhea, Pelvic Pain, Dyspareunia
- What is being tested?
- Oral contraceptives cyclic and Oral contraceptives continuous
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGreece
- Study dates
- Apr 2014to Dec 2015
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Women of reproductive age with Symptomatic endometriosis following fertility sparing surgery
Who cannot join
- Contraindications of use of oral contraceptives
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Aretaieion Hospital
Athens, Athens
Olga B Triantafyllidou, M.D, Msc, +306944963506, triantafyllidouolga@yahoo.com
Nikos Vlahos, AssProfessor
About this study
Official title: Continuous Versus Cyclic Use of Oral Contraceptives Following Surgery for Symptomatic Endometriosis
To evaluate the efficacy of oral contraceptives in a continuous fashion versus the usual cyclic fashion in the recurrence of endometriosis related symptoms and endometriomas following fertility-sparing surgery.
Read the detailed description
Oral contraceptives containing 0.03 mg ethinyl estradiol and 3mg drospirenone will be administered. One tablet a day for 21 days followed by 7 days pill free (cyclic fashion) or one tablet a day in a continuous fashion.
- Conditions
- Dysmenorrhea, Pelvic Pain, Dyspareunia, Endometrioma
- Being tested
- Oral contraceptives cyclic, Oral contraceptives continuous
- Keywords
- Endometriosis, Oral contraceptives, Laparoscopy
- Medical subject headings
- Dysmenorrhea, Pelvic Pain, Dyspareunia, Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral contraceptives cyclicDrug
Also called Yasmin.
tables containing Ethinyl estradiol 0.03mg and drospirenone 3mg will be administered in a cyclic fashion 21 days on 7 days off pill for 6 cycles.
Oral contraceptives continuousDrug
Also called Yasmin
Patients will be treated with oral contraceptives containing 0.03mg ethinyl estradiol and 3 mg drospirenone per day in a continuous fashion.
| Study group | Role | What they receive |
|---|---|---|
| Oral contraceptives cyclic | Experimental | Oral contraceptives containing 0.03 mg ethinyl estradiol and 3mg drospirenone will be administered. One tablet a day for 21 days followed by 7 days pill free. The regimen will be repeated for the duration of the trial. Receives: Drug: Oral contraceptives cyclic; Drug: Oral contraceptives continuous |
| Oral contraceptives continuous | Active comparator | Oral contraceptives containing 0.030 mg ethinyl estradiol and 3mg drospirenone will be administered. One tablet a day for the duration of the trial. Receives: Drug: Oral contraceptives cyclic; Drug: Oral contraceptives continuous |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic pain
In each visit patients will complete a detailed 25-item self-administered questionnaire (www.endometriosisfoundation.org/WERF-WHSS-Questionnaire-English.pdf) related to the presence of pelvic pain (scoring of pelvic pain)
Measured: 6 months
Secondary outcomes (1)
recurrence rate for endometrioma
Physical and transvaginal sonographic examination
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2015 (estimated)
- Study completionDec 2015 (estimated)
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 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nikos Vlahos, University of Athens
- Investigators
- Nikos Vlahos, AssProfessor, Study chair, University of Athens, 2nd Department of Obstetrics and GynecologyOlga Triantafyllidou, MD, Principal investigator, University of Athens, 2nd Department of Obstetrics and Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02237131
- Sponsor's protocol ID
- NV04042013
- Status last verified
- Sep 2014
- First submitted
- 22 Mar 2014
- Last updated
- 11 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Versus Cyclic Use of Oral Contraceptives Following Surgery for Symptomatic Endometriosis
- ClinicalTrials.gov ID
- NCT02237131
- Acronym / sponsor ID
- NV04042013
- Conditions
- Dysmenorrhea, Pelvic Pain, Dyspareunia, Endometrioma
- Keywords
- Endometriosis, Oral contraceptives, Laparoscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 11 Sep 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.
To evaluate the efficacy of oral contraceptives in a continuous fashion versus the usual cyclic fashion in the recurrence of endometriosis related symptoms and endometriomas following fertility-sparing surgery.
Detailed description
Oral contraceptives containing 0.03 mg ethinyl estradiol and 3mg drospirenone will be administered. One tablet a day for 21 days followed by 7 days pill free (cyclic fashion) or one tablet a day in a continuous fashion.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral contraceptives cyclic | Experimental | Drug: Oral contraceptives cyclic, Drug: Oral contraceptives continuousOral contraceptives containing 0.03 mg ethinyl estradiol and 3mg drospirenone will be administered. One tablet a day for 21 days followed by 7 days pill free. The regimen will be repeated for the duration of the trial. |
| Oral contraceptives continuous | Active comparator | Drug: Oral contraceptives cyclic, Drug: Oral contraceptives continuousOral contraceptives containing 0.030 mg ethinyl estradiol and 3mg drospirenone will be administered. One tablet a day for the duration of the trial. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women of reproductive age with Symptomatic endometriosis following fertility sparing surgery
Key exclusion criteria (1 listed)
- Contraindications of use of oral contraceptives
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 |
|---|---|---|
| Oral contraceptives cyclicAlso: Yasmin.tables containing Ethinyl estradiol 0.03mg and drospirenone 3mg will be administered in a cyclic fashion 21 days on 7 days off pill for 6 cycles. | Drug | Oral contraceptives continuous, Oral contraceptives cyclic |
| Oral contraceptives continuousAlso: YasminPatients will be treated with oral contraceptives containing 0.03mg ethinyl estradiol and 3 mg drospirenone per day in a continuous fashion. | Drug | Oral contraceptives continuous, Oral contraceptives cyclic |
Primary outcome
Pelvic pain
Time frame: 6 months
In each visit patients will complete a detailed 25-item self-administered questionnaire (www.endometriosisfoundation.org/WERF-WHSS-Questionnaire-English.pdf) related to the presence of pelvic pain (scoring of pelvic pain)
1 secondary outcome
recurrence rate for endometrioma
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2014.
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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.
Nikos Vlahos, AssProfessor study chair
University of Athens, 2nd Department of Obstetrics and Gynecology
Olga Triantafyllidou, MD principal investigator
University of Athens, 2nd Department of Obstetrics and Gynecology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oral contraceptives cyclic and Oral contraceptives continuous in people with Dysmenorrhea and Pelvic Pain, run by University of Athens at 1 site in Greece.
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 1 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: status not confirmed, as of the sponsor's last update on 11 Sep 2014. 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 Greece. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olga B Triantafyllidou, M.D, Msc (+306944963506, triantafyllidouolga@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic pain (time frame: 6 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 11 Sep 2014.