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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
Sponsor:
Information provided by:

Study Description
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.


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

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
Study Start Date : May 2009
Estimated Primary Completion Date : May 2010
Estimated Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Estradiol
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Recurrence of pelvic pain [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Metabolic effects [ Time Frame: 12 months ]
  2. Ovarian effects [ Time Frame: 12 months ]
  3. Endometrial effects [ Time Frame: 12 months ]
  4. Bleedings characteristics [ Time Frame: 12 months ]
  5. Protocol adherence [ Time Frame: 12 months ]
  6. Satisfaction rate [ Time Frame: 12 months ]
  7. Adverse events [ Time Frame: 12 months ]
  8. Effects on cognitive function and mood [ Time Frame: 12 months ]
  9. Quality of life [ Time Frame: 12 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

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


Contacts
Contact: Stefano Palomba, MD +39-0961-883234 stefanopalomba@tin.it

Locations
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         
Sponsors and Collaborators
University Magna Graecia
More Information

Additional Information:
Responsible Party: Fulvio Zullo, University Magna Graecia
ClinicalTrials.gov Identifier: NCT00844012     History of Changes
Other Study ID Numbers: 01/2009
First Posted: February 13, 2009    Key Record Dates
Last Update Posted: March 12, 2009
Last Verified: February 2009

Additional relevant MeSH terms:
Endometriosis
Pelvic Pain
Genital Diseases, Female
Pain
Neurologic Manifestations
Signs and Symptoms
Estradiol
Polyestradiol phosphate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female