Continuous Postoperative Use of Low-Dose Combined Oral Contraceptivesfor for Endometriosis-Related Chronic Pelvic Pain
Continuous Versus Cyclic Postoperative Use of Low-Dose Combined Oral Contraceptive Belara® for the Treatment of Endometriosis-Related Chronic Pelvic Pain: a Randomized Controlled Trial.
1 other identifier
interventional
60
1 country
1
Brief Summary
Because ovarian sex steroids fluctuations during the menstrual cycle are implicated in the pathogenesis of the endometriosis-related chronic pelvic pain (CPP), the oral contraceptives (OCs) are used with non-contraceptive indication for this disorder. To date, OCs are widely used as medical treatment in patients with endometriosis, in addition, they are recently experimented as post-surgical therapy. Traditional cyclic regimen, with 21 days of active pills with 7 days of placebo or suspension, is usually adopted. Furthermore, recent studies suggested that long-term continuous OCs use can be effective in the postoperative period both as second- and third- line treatments after cyclic regimen failure. In these studies a combined treatment with ethinilestradiol (0.02 mg) plus desogestrel (0.15 mg) were used and compared with baseline or ciproterone acetate. A recent study showed a deeper ovarian and endometrial suppression with continuous OCs in comparison with cyclic OCs, providing a physiological rationale for continuous OCs use for noncontraceptive indications. Furthermore, to date, no study compared post-operative continuous versus cyclic OCs in patients with endometriosis-related CPP.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started May 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2009
CompletedFirst Posted
Study publicly available on registry
February 13, 2009
CompletedStudy Start
First participant enrolled
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedMarch 12, 2009
February 1, 2009
1 year
February 12, 2009
March 10, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Recurrence of pelvic pain
12 months
Secondary Outcomes (9)
Metabolic effects
12 months
Ovarian effects
12 months
Endometrial effects
12 months
Bleedings characteristics
12 months
Protocol adherence
12 months
- +4 more secondary outcomes
Study Arms (2)
Experimental group
EXPERIMENTALControl
ACTIVE COMPARATORInterventions
Low-dose monophasic OC containing 2.0 mg clormadinone acetate plus 0.03 mg ethinil-estradiol (Belara®, Grunenthal, Milan, Italy) will be administered with a continuous regimen.
Low-dose monophasic OC containing 2.0 mg clormadinone acetate plus 0.03 mg ethinil-estradiol (Belara®, Grunenthal, Milan, Italy) will be administered with a cyclic regimen.
Eligibility Criteria
You may qualify if:
- Premenopausal state
- Endometriosis-related chronic pelvic pain
- Hystologically confirmed endometriosis at laparoscopy
- Subjective severity of pelvic pain by using a visual analogue scale of at least 70
- No immediate desire of pregnancy
You may not qualify if:
- Age ≤18 or ≥ 40
- Contraindication to estro-progestin compounds
- Major medical diseases
- Psychiatric disorders
- Pelvic inflammatory disease
- Adnexal patologies
- Unability to complete the daily diary
- History of alcohol or other drugs abuse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Catanzaro, Italy
Catanzaro, 88100, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 12, 2009
First Posted
February 13, 2009
Study Start
May 1, 2009
Primary Completion
May 1, 2010
Study Completion
July 1, 2010
Last Updated
March 12, 2009
Record last verified: 2009-02