Continuous Postoperative Use of Low-Dose Combined Oral Contraceptivesfor for Endometriosis-Related Chronic Pelvic Pain
Unknown statusPhase 4NCT00844012
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- 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.
- Conditions
- Interventions
- Drug: Continuous OC (clormadinone acetate plus ethinil-estradiol - Belara®, Grunenthal, Milan, Italy)
- Drug: Cyclic OC (clormadinone acetate plus ethinil-estradiol)
- Sponsor
- University Magna Graecia
- Start date
- 2009-05
- Primary completion
- 2010-05
- Sex
- Female
- Age range
- from 18 Years to 40 Years
- Results posted
- No results posted in this snapshot
- Countries
- Italy
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00844012