A prospective, single-arm, open-label study to determine the safety and effectiveness of a fixed-dose combination of camylofin and mefenamic acid in Indian women with primary dysmenorrhea


  • Pragya Pandey Department of Gynecology, Oriana Hospital, Ravindrapuri, Varanasi, Uttar Pradesh, India
  • Ayushi Asava Department of Gynecology Alliance Munot Hospital, New Timber Market, Shankashet Road, Bhavani Peth, Pune, Maharashtra, India
  • K. Hemalatha Nagaraj Udbhava Hospital, Ittamadu, Banshankari 3rd stage, Banshankari, Bengaluru, Karnataka, India
  • Sudhanshu Kumar Rath Kalinga Institutes of Medical Sciences, Campus No 5, KIIT University Road, Bhubaneswar, Odisha, India
  • Vijaya Lakshmi Kodati Vasavi Medical and Research Center, Lakdikapul, Khairatabad, Hyderabad, Telangana, India




Camylofin, Mefenamic acid, Primary dysmenorrhea, VAS


Background: Treatment of dysmenorrhea is aimed at providing symptomatic relief from associated pain. A prospective, single-arm, open-label, multicenter study was conducted at 5 sites across India to assess the safety, effectiveness and tolerability of a fixed-dose combination (FDC) of camylofin 50 mg and mefenamic acid 250 mg in women with primary dysmenorrhea.

Methods: Women were prescribed a 3/5-day course of the FDC orally thrice daily. The primary endpoint was to assess the safety of the FDC as analyzed by incidence of adverse events (AEs), and the main secondary endpoint was to evaluate effectiveness by change in mean intensity of pain as assessed by visual analog scale (VAS) scoring from baseline to day 3/5.

Results: Out of 274 enrolled women, pain associated with menses was reported by 271 (98.9%) women at baseline. In all, 28 (10.2%) women reported treatment-emergent AEs. The most common AEs were back pain, headache, vomiting, and upper abdominal pain, which were of mild intensity and resolved at the end of treatment (EoT). None of the women discontinued the study due to AEs. No serious AEs or deaths were reported in the study. The mean (standard deviation [SD]) pain intensity on VAS scale was 72.6 (16.28) at baseline and 3.3 (7.11) at EoT. A statistically significant reduction of 69.9 (18.60) from baseline in mean pain intensity was observed after treatment (p<0.0001).

Conclusions: An FDC of camyolfin and mefenamic acid had a good safety and tolerability profile and could effectively relieve pain in Indian women with primary dysmenorrhea.


Harel Z. Dysmenorrhea in adolescents and young adults: from pathophysiology to pharmacological treatments and management strategies. Expert Opin Pharmacother. 2008;9(15):2661-72.

Dawood MY. Dysmenorrhea. Infertil Reprod Med Clin N Am. 1995;6:363-77.

Latthe P, Latthe M, Say L, Gülmezoglu M, Khan KS. WHO systematic review of prevalence of chronic pelvic pain: a neglected reproductive health morbidity. BMC Public Health. 2006;6:177.

Harlow SD and Campbell OM. Epidemiology of menstrual disorders in developing countries: a systematic review. BJOG. 2004;111(1):6-16.

Agarwal AK, Agarwal A. A study of dysmenorrhea during menstruation in adolescent girls. Indian J Community Med. 2010;35(1):159-64.

Patel V, Tanksale V, Sahasrabhojanee M, Gupte S, Nevrekar P. The burden and determinants of dysmenorrhoea: a population-based survey of 2262 women in Goa, India. BJOG. 2006;113(4):453-63.

Omidvar S, Bakouei F, Amiri FN, Begum K. Primary dysmenorrhea and menstrual symptoms in Indian female students: Prevalence, impact and management. Glob J Health Sci. 2016;8(8):135-44.

Burnett M, Lemyre M. No. 345-Primary Dysmenorrhea Consensus Guideline. J Obstet Gynaecol Can. 2017;39(7):585-95.

Nor Azlin MI, Maryasalwati I, Norzilawati MN, Mahdy ZA, Jamil MA, Zainul Rashid MR. The efficacy of etoricoxib vs mefenamic acid in the treatment of primary dysmenorrhoea: a randomized comparative study. J Obstet Gynaecol. 2008;28(4):424-6.

Cimolai N. The potential and promise of mefenamic acid. Expert Rev Clin Pharmacol. 2013;6(3):289-305.

Pulkkinen MO. Suppression of uterine activity by prostaglandin synthetase inhibitors. Acta Obstet Gynecol Scand. 1979;87:39-43.

Tilyard MW, Dovey SM. A comparison of tiaprofenic acid, mefenamic acid and placebo in the treatment of dysmenorrhoea in general practice. Aust N Z J Obstet Gynaecol. 1992;32(2):165-8.

Roy S. A double-blind comparison of a propionic acid derivative (ibuprofen) and a fenamate (mefenamic acid) in the treatment of dysmenorrhea. Obstet Gynecol. 1983;61(5):628-32.

Hébert JG, Le Morvan P, Bourgouin J. Double-blind comparison of ketoprofen and mefenamic acid in the treatment of primary dysmenorrhea. Clin Ther. 1986;8(3):329-35.

Serfaty D. A comparative crossover study of piroxicam vs. mefenamic acid and diclofenac in France. Acta Obstet Gynecol Scand Suppl. 1986;138:19-20.

De Mello NR, Baracat EC, Tomaz G, Bedone AJ, Camargos A, Barbosa IC et al. Double-blind study to evaluate efficacy and safety of meloxicam 7.5 mg and 15 mg versus mefenamic acid 1500 mg in the treatment of primary dysmenorrhea. Acta Obstet Gynecol Scand. 2004;83(7):667-73.

Anderson AB, Haynes PJ, Fraser IS, Turnbull AC. Study of prostaglandin synthetase inhibitors in primary dysmenorrhoea. Lancet. 1978;1(8060):345-48.

Warke HS, Chauhan AR, Raut VS, Ingle KM. A Randomised Double-Blind Study-Bombay Hospital J. 2003.

Proctor M, Farquhar C. Diagnosis and management of dysmenorrhoea. BMJ. 2006;332(7550):1134-8.

Gupta C. Use of Anafortan Intravenous injection for treatment of colicky pain. J Indian Med Assoc. 2000;98(8):479-82.

Dhandapani S, Das S, Gangadhar A. A randomised, comparative study to evaluate the efficacy and tolerability of two fixed dose combinations of camylofin and mefenamic acid and dicyclomine and mefenamic acid in the management of primary dysmenorrhea. Indian Practitioner. 2019;70(2):16-20.






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