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CompletedNCT03104309Updated Apr 14, 2017

Levonorgestrel Intrauterine System and Adenomyosis

An interventional study of Levonorgestrel intrauterine system in Adenomyosis, sponsored by Assiut University. Completed. Open to female participants aged 20 Years to 45 Years. Per ClinicalTrials.gov, last updated 2017-04-14.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 10 months after the study started (first participant enrolled Jun 2015, registered Apr 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
20 Years to 45 Years
Sex
Female
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Study summary

Adenomyosis is defined when the endometrial tissue (gland and stroma) is present within the myometrium . The depth of endometrial penetration which uses in diagnosis of adenomyosis not yet agreed; opinions range from one high power field to 25% of the myometrial thickness. It is a common condition in women aged 40-50 years and is considered an important cause of dysmenorrhea and menorrhagia in around 65 % of cases.

Until past few years; hysterectomy was the suggested definitive treatment, however; this may not be acceptable to women not willing to loss their fertility. Many treatment lines were studied and proved their beneficial effect on adenomyosis such as GnRH agonists, danazol, combined oral contraceptive pills, dienogest and finally endometrial ablation. However, these line of treatment are not commonly used because high incidence of side effects and relatively high cost of some of them.

The levonorgestrel-releasing intrauterine system (LNG-IUS) was emerged as an effective line for treatment of adenomyosis associated pain and bleeding. It can successfully, within 6 to 12 months, down-regulate the estrogen receptors in adenomyotic tissues which lead to decidualization and atrophy of the adenomyosis .

In fact, some adenomyotic women respond well to LNG-IUDs and show high acceptability and satisfaction, on the other hand; a group of women may not respond to LNG-IUDs and opt to remove it and start a new medical or surgical option for treatment.

However, factors related to LNG-IUS effectiveness in patients with adenomyosis were not well available. Only one report states that a large uterine volume could be a factor associated with LNG-IUS treatment discontinuation in adenomyotic patient.

For this reason; the prediction of the responsiveness to LNG-IUS is interesting issue which should be addressed. The present study examines the hypothesis that patient's data reported at baseline visit before using LNG-IUSfor controlling pain/bleeding with adenomyosis can help the prediction of the responsiveness for this important line of treatment at 6 months follow up visit. Up to our knowledge; no clinical trial had been registered or conducted to predict the responsiveness for LNG-IUS in controlling the pain/ bleeding with adenomyosis.

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Conditions studied

  • Adenomyosis

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03

In context

Adenomyosis

135 studies on the registry are indexed under Adenomyosis; 50 are open to participants now.

This study's enrollment of 100 is close to the median of 100 across 73 interventional studies indexed under Adenomyosis.

Browse Adenomyosis studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • adenomyosis
  • request for contraception
  • resident in the nearby vicinity to make the follow-up easy and feasible

Exclusion criteria

Exclusion Criteria:

  • history of ectopic pregnancy
  • puerperal sepsis
  • pelvic inflammatory disease
  • evidence of coagulopathy
  • abnormalities of the uterine cavity
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Other
    Levonorgestrel intrauterine system

    Device: Levonorgestrel intrauterine system

Interventions

  • DeviceLevonorgestrel intrauterine system

    Levonorgestrel intrauterine system for adenomyosis

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What researchers measure

Primary outcomes

  1. number of bleeding days per months

    Time frame: 6 months

  2. The degree of pain perception by visual analogue scale

    Time frame: 6months

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 14, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03104309
Lead sponsor
Assiut University
Responsible party
Mohammed Khairy Ali (Dr, Assiut University) — Principal investigator
First posted
Apr 7, 2017
Start date
Jun 2015
Primary completion
Jul 2016
Completion
Aug 2016
Last update
Apr 14, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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