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Functional Near-Infrared Spectroscopy Hyperscanning Study in Psychological Counseling
Published on: January 17, 2025
Bleeding patterns with the 19.5 mg LNG-IUS, with special focus on the first year of use: implications for counselling
Vita Beckert1, Christiane Ahlers1, Ann-Kathrin Frenz1
1a Bayer AG , Berlin , Germany.
Insights
Early bleeding patterns with the 19.5 mg levonorgestrel-releasing intrauterine system (LNG-IUS) show a progressive decline over 12 months. This detailed insight aids in counseling women on contraceptive choice and continuation.
Area of Science:
- Reproductive Health
- Contraception
- Gynecology
Background:
- Understanding early bleeding patterns is crucial for effective use and continuation of hormonal contraceptives.
- The 19.5 mg levonorgestrel-releasing intrauterine system (LNG-IUS) is a widely used contraceptive method.
- Detailed data on the initial bleeding profile of the 19.5 mg LNG-IUS is needed for patient counseling.
Purpose of the Study:
- To provide a detailed description of early bleeding and spotting patterns associated with the 19.5 mg LNG-IUS.
- To analyze the influence of prior contraceptive methods on bleeding patterns with the 19.5 mg LNG-IUS.
- To assess changes in bleeding and spotting days over a 12-month period.
Main Methods:
- Pooled analysis of bleeding diaries from phase II and phase III randomized controlled studies of the 19.5 mg LNG-IUS.
- Inclusion of data from a 2-year extension phase.
- Median number of bleeding/spotting days per 30-day period analyzed for 12 months.
Main Results:
- A progressive decline in bleeding and/or spotting days was observed from month 1 to month 12.
- The proportion of women experiencing ≤4 bleeding/spotting days increased from 6.2% at month 1 to 54.1% at month 12.
- Women previously using an LNG-IUS had the lowest median number of bleeding/spotting days in the first month.
Conclusions:
- Detailed analysis of bleeding diaries provides valuable insights into early bleeding changes with the 19.5 mg LNG-IUS.
- These findings can assist healthcare providers in counseling women regarding contraceptive choices.
- Understanding bleeding patterns can improve method continuation rates for the 19.5 mg LNG-IUS.
Abstract:
Objective: The aim of the study was to provide an additional, detailed description of early bleeding patterns with the 19.5 mg levonorgestrel-releasing intrauterine system (LNG-IUS). Methods: We conducted a pooled analysis of the bleeding diaries of participants in a previously reported phase II randomised controlled study (n = 741) and a phase III study (n = 2904), with 2-year extension phase (n = 707), of the 19.5 mg LNG-IUS. Main outcome measures were the median number of bleeding and/or spotting days per 30-day reference period for 12 months and the influence of the previous contraceptive method and levonorgestrel dose on bleeding patterns. Results: The pooled analysis comprised 1697 women. There was a progressive decline in the number of bleeding and/or spotting days from month 1: the proportion of women with ≤4 bleeding and/or spotting days per month increased from 6.2% in month 1 to 15.8% in month 2, 26.0% in month 3, 39.3% in month 6 and 54.1% in month 12. The median number of bleeding and/or spotting days in month 1 was lowest in women who had previously been using an LNG-IUS. Conclusion: Analysis of bleeding diaries using 30-day reference periods provides detailed insight into bleeding changes in the first months following placement of the 19.5 mg LNG-IUS. This insight may prove useful when counselling women about contraceptive choice and method continuation.
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