Continuous Postoperative Use of Low-Dose Combined Oral Contraceptivesfor for Endometriosis-Related Chronic Pelvic Pain
Recruitment status was Not yet recruiting
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Purpose
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 | Intervention | 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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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. |
- Recurrence of pelvic pain [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Metabolic effects [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Ovarian effects [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Endometrial effects [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Bleedings characteristics [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Protocol adherence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Satisfaction rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Effects on cognitive function and mood [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | July 2010 |
| Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
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| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Stefano Palomba, MD | +39-0961-883234 | stefanopalomba@tin.it |
| Italy | |
| University of Catanzaro, Italy | Not yet recruiting |
| Catanzaro, Italy, 88100 | |
| Contact: Fulvio Zullo, MD +3909613697180 zullo@unicz.it | |
| Principal Investigator: Stefano Palomba, MD | |
| Principal Investigator: Fulvio Zullo, MD | |
More Information
Additional Information:
No publications provided
| Responsible Party: | Fulvio Zullo, University Magna Graecia |
| ClinicalTrials.gov Identifier: | NCT00844012 History of Changes |
| Other Study ID Numbers: | 01/2009 |
| Study First Received: | February 12, 2009 |
| Last Updated: | March 10, 2009 |
| Health Authority: | Italy: The Italian Medicines Agency |
Additional relevant MeSH terms:
|
Pelvic Pain Endometriosis Genital Diseases, Female Pain Signs and Symptoms Contraceptives, Oral Contraceptives, Oral, Combined Estradiol Polyestradiol phosphate Estradiol valerate Estradiol 3-benzoate |
Estradiol 17 beta-cypionate Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |
ClinicalTrials.gov processed this record on May 23, 2013