Comparison of Estrogen-progestin Therapy in Continuous Regimen Versus Combination Estrogen-progestin Therapy in Continuous Regimen Plus Levonorgestrel-releasing Intrauterine System (LNG-IUS)
Primary Purpose
Adenomyosis, Chronic Pelvic Pain
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
LNG-IUS 13,5 mg Levonorgestrel
Levonorgestrel 0,10 mg+ ethinylestradiol 0,02 mg
Sponsored by
About this trial
This is an interventional treatment trial for Adenomyosis
Eligibility Criteria
Inclusion Criteria:
- Women affected by adenomyosis with pelvic pain > 4;
- Negative Pap Smear test
Exclusion Criteria:
- Pregnancy or research of pregnancy
- Refusal or inability to sign informed consent
- Severe underlying comorbidities (hepatic, oncological)
- Pelvic inflammatory disease
- Other cervical or uterine pathologies
- Deep venous thromboembolism
- Hormonal therapy contraindications
- Smoke
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
LNG-IUS
combined oral contraceptive plus LNG-IUS
Arm Description
LNG-IUS 13,5 mg di Levonorgestrel
Levonorgestrel 0,10 mg+ ethinylestradiol 0,02 mg+ LNG-IUS 13,5 mg di Levonorgestrel
Outcomes
Primary Outcome Measures
Change of Pelvic pain as measured by visual analogue scale
Secondary Outcome Measures
Change of Pelvic pain as measured by visual analogue scale
Change of Pelvic pain as measured by visual analogue scale
Change of Pelvic pain as measured by visual analogue scale
Quality of sexual life
Full Information
NCT ID
NCT02556411
First Posted
September 20, 2015
Last Updated
February 3, 2021
Sponsor
University of Cagliari
1. Study Identification
Unique Protocol Identification Number
NCT02556411
Brief Title
Comparison of Estrogen-progestin Therapy in Continuous Regimen Versus Combination Estrogen-progestin Therapy in Continuous Regimen Plus Levonorgestrel-releasing Intrauterine System (LNG-IUS)
Official Title
Comparison of E/P Therapy in Continuous Regimen Versus Combination of LNG-IUS Plus E/P
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2021 (Anticipated)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
June 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cagliari
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Adenomyosis is characterized by the appearance of endometrial cells in the muscular layer of the uterus. It affects about 15-20% of the female population.
The symptoms of adenomyosis are heavy menstrual bleedings and painful menstruation (dysmenorrhea) and in addition chronic pelvic pain. Regarding treatment levonogestrel-releasing intrauterine system, Gonadotropin releasing hormone (GnRH)-analogues, Danazol, uterine embolization and endometrial ablation have been tried. The aim of this study is to compare the efficacy and usefulness of association of oral contraceptive pill and LNG-IUS or LNG-IUS alone
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenomyosis, Chronic Pelvic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LNG-IUS
Arm Type
Active Comparator
Arm Description
LNG-IUS 13,5 mg di Levonorgestrel
Arm Title
combined oral contraceptive plus LNG-IUS
Arm Type
Experimental
Arm Description
Levonorgestrel 0,10 mg+ ethinylestradiol 0,02 mg+ LNG-IUS 13,5 mg di Levonorgestrel
Intervention Type
Drug
Intervention Name(s)
LNG-IUS 13,5 mg Levonorgestrel
Intervention Description
LNG-IUS
Intervention Type
Drug
Intervention Name(s)
Levonorgestrel 0,10 mg+ ethinylestradiol 0,02 mg
Intervention Description
Levonorgestrel 0,10 mg+ethinylestradiol 0,02 mg oral contraceptive pill in continuous regime
Primary Outcome Measure Information:
Title
Change of Pelvic pain as measured by visual analogue scale
Time Frame
Change from baseline pelvic pain at 45 days of treatment
Secondary Outcome Measure Information:
Title
Change of Pelvic pain as measured by visual analogue scale
Time Frame
Change from baseline pelvic pain at 90 days of treatment
Title
Change of Pelvic pain as measured by visual analogue scale
Time Frame
Change from baseline pelvic pain at 180 days of treatment
Title
Change of Pelvic pain as measured by visual analogue scale
Time Frame
Change from baseline pelvic pain at 365 days of treatment
Title
Quality of sexual life
Time Frame
Cases were administered and fulfilled the questionnaires at the moment of diagnosis of adenomyosis up to 4weeks; Change from baseline were evaluated 45 days after begin of treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Women affected by adenomyosis with pelvic pain > 4;
Negative Pap Smear test
Exclusion Criteria:
Pregnancy or research of pregnancy
Refusal or inability to sign informed consent
Severe underlying comorbidities (hepatic, oncological)
Pelvic inflammatory disease
Other cervical or uterine pathologies
Deep venous thromboembolism
Hormonal therapy contraindications
Smoke
12. IPD Sharing Statement
Learn more about this trial
Comparison of Estrogen-progestin Therapy in Continuous Regimen Versus Combination Estrogen-progestin Therapy in Continuous Regimen Plus Levonorgestrel-releasing Intrauterine System (LNG-IUS)
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