Comparison of Estrogen-progestin Therapy in Continuous Re... | NCT02556411

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

NCT02556411

Sponsor

University of Cagliari

Status

Unknown status

Last Update Posted

Feb 4, 2021Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Adenomyosis
Chronic Pelvic Pain

Interventions

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

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2021Estimated

Primary Completion Date

Dec 1, 2021Estimated

Completion Date

Jun 1, 2022Estimated

First Submitted Date

Sep 20, 2015

First Submission Date that Met QC Criteria

Sep 21, 2015

First Posted Date

Sep 22, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 3, 2021

Last Update Posted Date

Feb 4, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LNG-IUS	Active Comparator	LNG-IUS 13,5 mg di Levonorgestrel	Drug: LNG-IUS 13,5 mg Levonorgestrel
combined oral contraceptive plus LNG-IUS	Experimental	Levonorgestrel 0,10 mg+ ethinylestradiol 0,02 mg+ LNG-IUS 13,5 mg di Levonorgestrel	Drug: LNG-IUS 13,5 mg Levonorgestrel Drug: Levonorgestrel 0,10 mg+ ethinylestradiol 0,02 mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LNG-IUS 13,5 mg Levonorgestrel	Drug	LNG-IUS	LNG-IUS combined oral contraceptive plus LNG-IUS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change of Pelvic pain as measured by visual analogue scale		Change from baseline pelvic pain at 45 days of treatment

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D014591	Uterine Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D000091662	Genital Diseases