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Multicenter Study of Contraceptive Vaginal Ring (NuvaRing®) in Normal Daily Practice in Indian Women

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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.

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Acknowledgments

The authors thank the participating study investigators, Dr. Suchita Meherishi and Dr. Vijayalakshmi. This study was supported by Organon (India) Private Ltd, a subsidiary of Merck & Co. Inc., Whitehouse Station, NJ, USA.

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Authors and Affiliations

  1. Gynecology and Obstetrics, Kokilaben Dhirubhai Ambani Hospital, Rao Saheb Achutrao Patwardhan Marg, Andheri (West), Mumbai, 400 053, India

    Suchitra N. Pandit (Professor, Consultant Obstetrician and Gynecologists)

  2. Gynecology and Obstetrics, Seth G. S. Medical College & KEM Hospital, A. Donde Marg, Parel, Mumbai, 400 012, India

    Anahita R. Chauhan (Additional Professor and Unit Head)

  3. Department of Gynecology and Obstetrics, Yashoda Hospital, Raj Bhavan Road, Somajiguda, Hyderabad, 500 082, India

    Manjula Anagani (Head, Consultant Obstetrician and Gynecologists)

  4. Department of Gynecology and Obstetrics, Sri Ramchandra Medical College & Research Institute, Sri Ramchandra University, No. 1 Ramchandra Marg, Porur, Chennai, 600 116, India

    Sanjeeva Reddy (Professor and Head)

  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

    Ashish Birla (Senior Medical Advisor) & Subrat K. Ray (Associate Director)

Authors
  1. Suchitra N. Pandit
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  2. Anahita R. Chauhan
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  3. Manjula Anagani
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  4. Sanjeeva Reddy
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  5. Ashish Birla
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  6. Subrat K. Ray
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Corresponding author

Correspondence to Subrat K. Ray.

Additional information

Clinical Trials Registry of India (CTRI) number: NCT01490190.

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Pandit, S.N., Chauhan, A.R., Anagani, M. et al. Multicenter Study of Contraceptive Vaginal Ring (NuvaRing®) in Normal Daily Practice in Indian Women. J Obstet Gynecol India 64, 409–416 (2014). https://doi.org/10.1007/s13224-014-0559-7

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  • DOI: https://doi.org/10.1007/s13224-014-0559-7

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