A randomised controlled trial comparing the efficacy, acceptability and side-effect profile of intravaginal contraceptive ring (Nuvaring®) with oral combined estrogen and progestogen preparation in abnormal uterine bleeding- A pilot study
ESC Congress Library. Jain S. May 4, 2016; 127060; A-234
Sandhya Jain
Sandhya Jain
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Abstract
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Objectives: Combined oral hormonal pills (COC) are being used in patients of abnormal uterine bleeding, especially adolescents and reproductive age women considering their need for contraception. It decreases the blood loss due to haemostatic effect of estrogen and also regularises the cycle. . Intravaginal route has been found to be effective and acceptable; Gastrointestinal absorption and hepatic first-pass metabolism is avoided and hormones are continuously absorbed by the vaginal mucosa producing steady, uniform blood concentration. Bioavailability of estrogen and progestogen through oral and vaginal route are same. The convenience of once-a-month administration is another major advantage. The objective of this study was to compare the bleeding pattern, side-effects and patient acceptability of intravaginal contraceptive ring (Nuvaring®) with combined oral hormonal preparation in patients with abnormal uterine bleeding.

  Material: Sixty women fulfilling inclusion criteria were divided into 2 groups in 1:1 ratio. In one group( n=30), monthly insertion of Nuvaring®)  was done for three consecutive months. Nuvaring®  releases 15µg ethinyl estradiol and 120 µg etnogesterol daily. The other group ( n=30) received combined oral hormonal pill containing 30µg EE and 150 µg levonorgestrel for three consecutive months.

Results: Both Nuvaring®  and COC were found to significant decrease blood loss in each cycle. Decrease in PBAC (pictorial blood loss assessment chart) score was more in Nuvaring®  group compared to COC, however difference was not significant.  Ideal bleed (IB) was frequently higher for Nuvaring®  group than COC in all 3 cycles, although no statistically significant difference was observed between groups (p-value=0.286). Late withdrawl, intermenstural spotting was higher in COC group. Compliance was better and women were more satisfied in Nuvaring®  group compared to COC group. Minor side effects like headache, mastalgia, nausea and mood changes were seen in both groups, which were not significant. Dysmenorrhea was relived in both groups; however decrease in dysmenorrhea was seen more in COC group. BMI was not found to be affected post therapy in both groups when compared with pre therapy value. Continuation rate was significantly higher in Nuvaring®  group. 30% women discontinued treatment in OCP group after 3 month compare to 10% in Nuvaring®  group.

Conclusion: Present study shows Nuvaring®  to be as effective as COC in controlling heavy menstural bleed, better cycle control, with minor acceptable systemic side effects.  .

 

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