Menstrual Pattern Within Six Months of Levonogestrel IUS Insertion

August 27, 2024 updated by: Mariam Samy Lotfy, Assiut University

The Prevalence and Predictors of 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Females at reproductive age (18-45)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Six months after insertion of levonogestrel Intrauterine system

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Seif E Ahmed, Professor, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

August 27, 2024

First Submitted That Met QC Criteria

August 27, 2024

First Posted (Actual)

August 29, 2024

Study Record Updates

Last Update Posted (Actual)

August 29, 2024

Last Update Submitted That Met QC Criteria

August 27, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • Contraception

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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