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NCT Number: NCT06577168

Menstrual Pattern Within Six Months of Levonogestrel IUS Insertion

The purpose of this study is to systematically calculate the mean number of bleeding-only, spotting-only, and bleeding and/or spotting days experienced by a population of reproductive aged,52 mg levonogestrel Intrauterine System(LNG-IUS) users.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

About this study

The levonogestrel Intrauterine system (LNG-IUS)(52 mg per 20mg per day release) is associated with medically benign changes to the menstrual pattern. Amenorrhea, the complete cessation of vaginal bleeding for at least 90 consecutive days, is perhaps the most extreme bleeding pattern experienced by some users during the first year. Amenorrhea prevalence is positively associated with duration of use, with approximately 8% of users.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Included participants with normal regular menses prior to LNG-IUS

insertion

  • Included participants of any age, race, ethnicity, or parity
  • Contained bleeding and/or spotting data on the 52 mg (20 mg/d) LNG-IUS
  • Collected daily menstrual bleeding data from written diaries for at least 90 consecutive days

Exclusion criteria

  • Heavy or prolonged menstrual bleeding (menorrhagia)
  • Actively breastfeeding
  • Hormonal long-acting reversible contraceptive method (LNG-IUS, implant) within 3 months of enrollment
  • Hormonal injectable contraceptive use within 6 months of enrollment
  • First 3 months (90 days) of data from women with postpartum or postabortion LNG-IUS insertions
  • Any anatomical or pathological condition (ie, uterine fibroids) that may have an impact on baseline menstrual bleeding pattern

Treatment and study plan

Levonogestrel Intrauterine system (LNG-IUS)

Other

Contraception method

Primary outcomes

  1. Mean number of days with menstrual bleeding changes

    Time frame: Six months after insertion of levonogestrel Intrauterine system

    This include calculating the average number of days per month with bleeding-only, spotting-only,and bleeding and/or spotting in reproductive aged women using a 52 mg levonogestrel Intrauterine system (LNG-IUS) within the first six months ofuse, according to World Health Organization standards.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed M Alaa eldin, Professor

CONTACT

[email protected]

+20 01006184921

Mariam S Lotfy

CONTACT

[email protected]

+20 01220270988

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

The Prevalence and Predictors of Menstrual Pattern Within Six Months of Levonogestrel IUS Insertion.

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Aug 29, 2024
Registry last updated
Aug 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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