Suchitra N Pandit1, Anahita R Chauhan2, Manjula Anagani3, Sanjeeva Reddy4, Ashish Birla5, Subrat K Ray5. 1. Gynecology and Obstetrics, Kokilaben Dhirubhai Ambani Hospital, Rao Saheb Achutrao Patwardhan Marg, Andheri (West), Mumbai, 400 053 India. 2. Gynecology and Obstetrics, Seth G. S. Medical College & KEM Hospital, A. Donde Marg, Parel, Mumbai, 400 012 India. 3. Department of Gynecology and Obstetrics, Yashoda Hospital, Raj Bhavan Road, Somajiguda, Hyderabad, 500 082 India. 4. Department of Gynecology and Obstetrics, Sri Ramchandra Medical College & Research Institute, Sri Ramchandra University, No. 1 Ramchandra Marg, Porur, Chennai, 600 116 India. 5. Medical Affairs, Organon (India) Private Limited, A subsidiary of Merck & Co. Inc., Whitehouse Stationi, NJ, USA, Platina Building, 8th Floor, C-59, G-Block, Bandra Kurla Complex, Bandra (East), Mumbai, 400051 India.
Abstract
OBJECTIVE: This was the first Indian multicenter study at six specialty hospitals, to assess the real-life usage of the vaginal ring in daily clinical practice. METHODS: This open-label, prospective, single-arm, nonrandomized, interventional study enrolled 252 women aged >18 years, seeking contraception with no contraindications to the use of combined hormonal contraceptive. Women were provided the ring with a monthly follow-up schedule for three cycles. Cycle control, acceptability, tolerability, and safety assessments were recorded at each visit. RESULTS: Regular menstrual bleeding was reported by 76.2 % (192/252) at baseline. In study completers, regular bleeding was seen in 94.1 % (192/204), 97.5 % (199/204), and 98 % (200/204) in the 1st, the 2nd, and the 3rd cycles, respectively. Most (94.2 % [195/207]) women were very satisfied or satisfied with the ring, and 93.2 % (193/207) would recommend it to others. No pregnancies or serious adverse events were reported. CONCLUSION: The study demonstrated that NuvaRing(®) is a highly effective contraceptive method with an excellent cycle control. It is well tolerated and accepted by Indian women.
OBJECTIVE: This was the first Indian multicenter study at six specialty hospitals, to assess the real-life usage of the vaginal ring in daily clinical practice. METHODS: This open-label, prospective, single-arm, nonrandomized, interventional study enrolled 252 women aged >18 years, seeking contraception with no contraindications to the use of combined hormonal contraceptive. Women were provided the ring with a monthly follow-up schedule for three cycles. Cycle control, acceptability, tolerability, and safety assessments were recorded at each visit. RESULTS: Regular menstrual bleeding was reported by 76.2 % (192/252) at baseline. In study completers, regular bleeding was seen in 94.1 % (192/204), 97.5 % (199/204), and 98 % (200/204) in the 1st, the 2nd, and the 3rd cycles, respectively. Most (94.2 % [195/207]) women were very satisfied or satisfied with the ring, and 93.2 % (193/207) would recommend it to others. No pregnancies or serious adverse events were reported. CONCLUSION: The study demonstrated that NuvaRing(®) is a highly effective contraceptive method with an excellent cycle control. It is well tolerated and accepted by Indian women.
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