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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

About this trial

This is an interventional treatment trial for Adenomyosis

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

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

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

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

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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