Clinical trial NCT00844012: Continuous Postoperative Use of Low-Dose Combined Oral Contraceptivesfor for Endometriosis-Related Chronic Pelvic Pain
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Endometriosis
Chronic Pelvic Pain
Lead sponsor: University Magna Graecia
Sponsor class: OTHER
First posted: 2009-02-13
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Age ≤18 or ≥ 40
* Previous use of drugs for treating CPP (wash-out period of 3 months), with exclusion of non-steroidal anti-inflammatory drugs
* 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

Primary outcomes:
measure: Recurrence of pelvic pain
timeFrame: 12 months
Secondary outcomes:
measure: Metabolic effects
timeFrame: 12 months
measure: Ovarian effects
timeFrame: 12 months
measure: Endometrial effects
timeFrame: 12 months
measure: Bleedings characteristics
timeFrame: 12 months
measure: Protocol adherence
timeFrame: 12 months
measure: Satisfaction rate
timeFrame: 12 months
measure: Adverse events
timeFrame: 12 months
measure: Effects on cognitive function and mood
timeFrame: 12 months
measure: Quality of life
timeFrame: 12 months
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: University of Catanzaro, Italy
Study officials:
References: