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

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

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

Study Overview

• Status: Unknown
• Conditions: Adenomyosis; Chronic Pelvic Pain
• Intervention / Treatment: Drug: LNG-IUS 13,5 mg Levonorgestrel; Drug: Levonorgestrel 0,10 mg+ ethinylestradiol 0,02 mg

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: University of Cagliari

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2021
• Primary Completion (ANTICIPATED): December 1, 2021
• Study Completion (ANTICIPATED): June 1, 2022

Study Registration Dates

• First Submitted: September 20, 2015
• First Submitted That Met QC Criteria: September 21, 2015
• First Posted (ESTIMATE): September 22, 2015

Study Record Updates

• Last Update Posted (ACTUAL): February 4, 2021
• Last Update Submitted That Met QC Criteria: February 3, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Uterine Diseases; Adenomyosis; Pelvic Pain; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Estrogens; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Contraceptives, Oral, Hormonal; Levonorgestrel; Ethinyl Estradiol
• Other Study ID Numbers: ADENOMYOSIS

Drug and device information, study documents

• 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