Ignite Creation Date:
2024-05-05 @ 9:14 PM
Last Modification Date:
2024-10-26 @ 10:01 AM
Study NCT ID:
NCT00844012
Status:
UNKNOWN
Last Update Posted:
2009-03-12
First Post:
2009-02-12
Brief Title:
Continuous Postoperative Use of Low-Dose Combined Oral Contraceptivesfor for Endometriosis-Related Chronic Pelvic Pain
Sponsor:
University Magna Graecia
Organization:
University Magna Graecia
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2009-02
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 002 mg plus desogestrel 015 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
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 002 mg plus desogestrel 015 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 20 mg clormadinone acetate plus 003 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
Briefly all patients will undergo conservative laparoscopic surgery for endometriosis Thereafter a low-dose monophasic OC containing 20 mg clormadinone acetate plus 003 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None