Menstrual Pattern Within Six Months of Levonogestrel IUS Insertion

Assiut University300 enrolled

Overview

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.

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

300

Conditions

Contraception

Interventions

Levonogestrel Intrauterine system (LNG-IUS)OTHER

Contraception method

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Assuit University

Asyut, Egypt

Outcomes

Primary Outcomes

Mean number of days with menstrual bleeding changes

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.

Time frame: Six months after insertion of levonogestrel Intrauterine system

Central Contacts

Mariam S Lotfy

CONTACT

+20 01220270988 mariomasamy90@gmail.com

Ahmed M Alaa eldin, Professor

CONTACT

+20 01006184921 Ahmedalla11282.eg@gmail.com

Data from ClinicalTrials.gov

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