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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02556411

Enrollment

Registered

2015-09-22

Start date

2021-06-01

Completion date

2022-06-01

Last updated

2021-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenomyosis, Chronic Pelvic Pain

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

Interventions

DRUGLNG-IUS 13,5 mg Levonorgestrel

LNG-IUS

DRUGLevonorgestrel 0,10 mg+ ethinylestradiol 0,02 mg

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Change of Pelvic pain as measured by visual analogue scale	Change from baseline pelvic pain at 90 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026