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Intrauterine Levonorgestrel Device in Patients with Endometriosis

The evaluation of changes in symptoms and findings of endometriosis patients with intrauterine levonorgestrel device

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614000015640
Enrollment
48
Registered
2014-01-07
Start date
2011-05-02
Completion date
2013-05-01
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

Our study showed that Levonorgestrel Intrauterine System improved the severity and frequency of pain, life quality assessment test scores, serum CA-125 levels and menstrual symptoms of patients with endometriosis.

Interventions

we inserted Levonorgestrel Intrauterin System(Lng-IUS) women aged between 23-48 with suspected symptomatic endometriosis. The procedure lasted about 2 minutes. Once it is inserted it stays in the uterus for 12 months untill the study is terminated. It is not inserted-reinserted, but inserted just once. The total intervention lasted for 12 months; the total duration of the study and continued after the study unless the patient desired otherwise.

Sponsors

Istanbul Medeniyet University Goztepe Education and Research Hospital
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
23 Years to 48 Years
Healthy volunteers
No

Inclusion criteria

All women have endometriosis symptoms. All of the women had regular menstrual periods (25–35 day intervals) for at least 6 months before particapting in the study, had not used any hormonal therapy for at least 6 months prior to the study. None of the women had been breastfeeding or had a desire to conceive in the ensuing 12 months. They had no history of osteoporosis, coagulation disorders, or contraindications to LNG-IUS.

Exclusion criteria

The exclusion criteria included non-diagnosed vaginal bleeding, gynecological cancer history, chronical diseases such as liver pathologies or diabetes mellitus, pelvic inflammatory disease, septic abortion history in the last 3 months, malignancy doubt in biopsies, fertility desire, the uterus size bigger than 10 weeks of gestational age, submucosal leiomyoma or polyp, having a diagnosis of a gynecologycal pathology other than endometriosis and a history of hormonal medication usage in the last 3 months.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026