Comparison of Estrogen-progestin Therapy in Continuous Regimen Versus Combination Estrogen-progestin Therapy in Continuous Regimen Plus Levonorgestrel-releasing Intrauterine System (LNG-IUS)

Sponsor

University of Cagliari (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT02556411

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Adenomyosis Chronic Pelvic Pain	Drug: LNG-IUS 13,5 mg Levonorgestrel Drug: Levonorgestrel 0,10 mg+ ethinylestradiol 0,02 mg	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Comparison of E/P Therapy in Continuous Regimen Versus Combination of LNG-IUS Plus E/P

Anticipated Study Start Date :

Jun 1, 2021

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: LNG-IUS LNG-IUS 13,5 mg di Levonorgestrel	Drug: LNG-IUS 13,5 mg Levonorgestrel LNG-IUS
Experimental: combined oral contraceptive plus LNG-IUS Levonorgestrel 0,10 mg+ ethinylestradiol 0,02 mg+ LNG-IUS 13,5 mg di Levonorgestrel	Drug: LNG-IUS 13,5 mg Levonorgestrel LNG-IUS Drug: Levonorgestrel 0,10 mg+ ethinylestradiol 0,02 mg Levonorgestrel 0,10 mg+ethinylestradiol 0,02 mg oral contraceptive pill in continuous regime

Arm

Intervention/Treatment

Active Comparator: LNG-IUS

LNG-IUS 13,5 mg di Levonorgestrel

Drug: LNG-IUS 13,5 mg Levonorgestrel

LNG-IUS

Experimental: combined oral contraceptive plus LNG-IUS

Levonorgestrel 0,10 mg+ ethinylestradiol 0,02 mg+ LNG-IUS 13,5 mg di Levonorgestrel

Drug: LNG-IUS 13,5 mg Levonorgestrel

LNG-IUS

Drug: Levonorgestrel 0,10 mg+ ethinylestradiol 0,02 mg

Levonorgestrel 0,10 mg+ethinylestradiol 0,02 mg oral contraceptive pill in continuous regime

Outcome Measures

Primary Outcome Measures

Change of Pelvic pain as measured by visual analogue scale [Change from baseline pelvic pain at 45 days of treatment]

Secondary Outcome Measures

Change of Pelvic pain as measured by visual analogue scale [Change from baseline pelvic pain at 90 days of treatment]
Change of Pelvic pain as measured by visual analogue scale [Change from baseline pelvic pain at 180 days of treatment]
Change of Pelvic pain as measured by visual analogue scale [Change from baseline pelvic pain at 365 days of treatment]
Quality of sexual life [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Cagliari

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Stefano Angioni, Associate Professor, University of Cagliari

ClinicalTrials.gov Identifier:

NCT02556411

Other Study ID Numbers:

ADENOMYOSIS

First Posted:

Sep 22, 2015

Last Update Posted:

Feb 4, 2021

Last Verified:

Feb 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 4, 2021