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

University of Cagliari

Status: Unknown

Conditions: Chronic Pelvic Pain; Adenomyosis

Treatments: Drug: LNG-IUS 13,5 mg Levonorgestrel; Drug: Levonorgestrel 0,10 mg+ ethinylestradiol 0,02 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT02556411

ADENOMYOSIS

Details and patient eligibility

About

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

Enrollment: 50 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

LNG-IUS

Active Comparator group

Description:

LNG-IUS 13,5 mg di Levonorgestrel

Treatment:

Drug: LNG-IUS 13,5 mg Levonorgestrel

combined oral contraceptive plus LNG-IUS

Experimental group

Description:

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

Treatment:

Drug: LNG-IUS 13,5 mg Levonorgestrel

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