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

Primary Purpose

Endometriosis, Chronic Pelvic Pain

Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Continuous OC (clormadinone acetate plus ethinil-estradiol - Belara®, Grunenthal, Milan, Italy)
Cyclic OC (clormadinone acetate plus ethinil-estradiol)
Sponsored by
University Magna Graecia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Catanzaro, Italy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group

Control

Arm Description

Outcomes

Primary Outcome Measures

Recurrence of pelvic pain

Secondary Outcome Measures

Metabolic effects
Ovarian effects
Endometrial effects
Bleedings characteristics
Protocol adherence
Satisfaction rate
Adverse events
Effects on cognitive function and mood
Quality of life

Full Information

First Posted
February 12, 2009
Last Updated
March 10, 2009
Sponsor
University Magna Graecia
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1. Study Identification

Unique Protocol Identification Number
NCT00844012
Brief Title
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

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Unknown status
Study Start Date
May 2009 (undefined)
Primary Completion Date
May 2010 (Anticipated)
Study Completion Date
July 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University Magna Graecia

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis, Chronic Pelvic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Title
Control
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Continuous OC (clormadinone acetate plus ethinil-estradiol - Belara®, Grunenthal, Milan, Italy)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Cyclic OC (clormadinone acetate plus ethinil-estradiol)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recurrence of pelvic pain
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Metabolic effects
Time Frame
12 months
Title
Ovarian effects
Time Frame
12 months
Title
Endometrial effects
Time Frame
12 months
Title
Bleedings characteristics
Time Frame
12 months
Title
Protocol adherence
Time Frame
12 months
Title
Satisfaction rate
Time Frame
12 months
Title
Adverse events
Time Frame
12 months
Title
Effects on cognitive function and mood
Time Frame
12 months
Title
Quality of life
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stefano Palomba, MD
Phone
+39-0961-883234
Email
stefanopalomba@tin.it
Facility Information:
Facility Name
University of Catanzaro, Italy
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fulvio Zullo, MD
Phone
+3909613697180
Email
zullo@unicz.it
First Name & Middle Initial & Last Name & Degree
Stefano Palomba, MD
First Name & Middle Initial & Last Name & Degree
Fulvio Zullo, MD

12. IPD Sharing Statement

Learn more about this trial

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

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