Continuous Postoperative Use of Low-Dose Combined Oral Contraceptivesfor for Endometriosis-Related Chronic Pelvic Pain
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|ClinicalTrials.gov Identifier: NCT00844012|
Recruitment Status : Unknown
Verified February 2009 by University Magna Graecia.
Recruitment status was: Not yet recruiting
First Posted : February 13, 2009
Last Update Posted : March 12, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Endometriosis Chronic Pelvic Pain||Drug: Continuous OC (clormadinone acetate plus ethinil-estradiol - Belara®, Grunenthal, Milan, Italy) Drug: Cyclic OC (clormadinone acetate plus ethinil-estradiol)||Phase 4|
Premenopausal women with endometriosis-related CPP scheduled for laparoscopic surgery to our Academic Department of Gynecology will be consecutively enrolled. Subjects with hystologically confirmed endometriosis at laparoscopy (stage I-IV of the American Society Reproductive Medicine), a subjective severity of pelvic pain by using a visual analogue scale (VAS 1-100) of at least 70, and without immediate desire of pregnancy will be enrolled.
Briefly, all patients will undergo conservative laparoscopic surgery for endometriosis. Thereafter, a low-dose monophasic OC containing 2.0 mg clormadinone acetate plus 0.03 mg ethinil-estradiol (Belara®, Grunenthal, Milan, Italy) will be administered. Patients from the experimental group will be treated with a continuous regimen, while patients from the control group will receive the OC with a cyclic regimen consisting of 21 days of active pills with 7 days of placebo. The drug and the placebo will be similar and will be labelled according to the subject number. For the overall study-period, operators and patients will be blind to the treatment allocation.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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.|
|Study Start Date :||May 2009|
|Estimated Primary Completion Date :||May 2010|
|Estimated Study Completion Date :||July 2010|
|Experimental: Experimental group||
Drug: Continuous OC (clormadinone acetate plus ethinil-estradiol - Belara®, Grunenthal, Milan, Italy)
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.
|Active Comparator: Control||
Drug: Cyclic OC (clormadinone acetate plus ethinil-estradiol)
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.
- Recurrence of pelvic pain [ Time Frame: 12 months ]
- Metabolic effects [ Time Frame: 12 months ]
- Ovarian effects [ Time Frame: 12 months ]
- Endometrial effects [ Time Frame: 12 months ]
- Bleedings characteristics [ Time Frame: 12 months ]
- Protocol adherence [ Time Frame: 12 months ]
- Satisfaction rate [ Time Frame: 12 months ]
- Adverse events [ Time Frame: 12 months ]
- Effects on cognitive function and mood [ Time Frame: 12 months ]
- Quality of life [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00844012
|Contact: Stefano Palomba, MDemail@example.com|
|University of Catanzaro, Italy||Not yet recruiting|
|Catanzaro, Italy, 88100|
|Contact: Fulvio Zullo, MD +3909613697180 firstname.lastname@example.org|
|Principal Investigator: Stefano Palomba, MD|
|Principal Investigator: Fulvio Zullo, MD|