Contraception
Conditions
Brief summary
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.
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.
Interventions
Contraception method
Sponsors
Assiut University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean number of days with menstrual bleeding changes | 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. |
Countries
Egypt
Contacts
Primary ContactMariam S Lotfy
Backup ContactAhmed M Alaa eldin, Professor
Outcome results
None listed