Menstrual Pattern Within Six Months of Levonogestrel IUS Insertion

Assiut University

Status: Not yet enrolling

Conditions: Contraception

Treatments: Other: Levonogestrel Intrauterine system (LNG-IUS)

Study type: Observational

Funder types: Other

Identifiers

NCT06577168

Contraception

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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