Continuous Postoperative Use of Low-Dose Combined Oral Contraceptivesfor for Endometriosis-Related Chronic Pelvic Pain

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by University Magna Graecia.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University Magna Graecia
ClinicalTrials.gov Identifier:
NCT00844012
First received: February 12, 2009
Last updated: March 10, 2009
Last verified: February 2009
  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.

Resource links provided by NLM:


Further study details as provided by University Magna Graecia:

Primary Outcome Measures:
  • Recurrence of pelvic pain [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
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:
Endometriosis
Pelvic Pain
Genital Diseases, Female
Pain
Signs and Symptoms
Contraceptives, Oral
Contraceptives, Oral, Combined
Estradiol
Polyestradiol phosphate
Estradiol valerate
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
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 August 18, 2014