Continuous Postoperative Use of Low-Dose Combined Oral Contraceptivesfor for Endometriosis-Related Chronic Pelvic Pain
|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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00844012
|Contact: Stefano Palomba, MDfirstname.lastname@example.org|
|University of Catanzaro, Italy||Not yet recruiting|
|Catanzaro, Italy, 88100|
|Contact: Fulvio Zullo, MD +3909613697180 email@example.com|
|Principal Investigator: Stefano Palomba, MD|
|Principal Investigator: Fulvio Zullo, MD|