A Multicentre, Prospective, Open-label, Non-comparative Study

Summary

As there are no recent studies conducted in Italy on the profile of this COC, the purpose of this study is to evaluate its efficacy and tolerability in a given subset of women residing in Italy that are in need of contraception. Evaluate the cycle control: breakthrough bleeding (bleeding and/or spotting between cyclically regular onset of menses) of monophasic oral contraceptive pill Effimia® (NGM250 + EE35) in a population of women residing in Italy.

Timeline

Start

2023-07-20

Primary completion

2023-12

Completion

2024-06

Publications

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• Background Evans SM, Haney M, Levin FR, Foltin RW, Fischman MW. Mood and performance changes in women with premenstrual dysphoric disorder: acute effects of alprazolam. Neuropsychopharmacology. 1998 Dec;19(6):499-516. doi: 10.1016/S0893-133X(98)00064-5.
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• Background Mannarini, S., Polimeni, S., Shams, M., & Giacobbo, M. (2012). Assessing negative and positive mood states: The identification of a short form of the POMS scale in Italian oncology outpatients. TPM - Testing, Psychometrics, Methodology in Applied Psychology, 19(2), 135- 145. https://doi.org/10.4473/TPM19.2.5
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• Background Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208. doi: 10.1080/009262300278597.
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• Background Filocamo MT, Serati M, Li Marzi V, Costantini E, Milanesi M, Pietropaolo A, Polledro P, Gentile B, Maruccia S, Fornia S, Lauri I, Alei R, Arcangeli P, Sighinolfi MC, Manassero F, Andretta E, Palazzetti A, Bertelli E, Del Popolo G, Villari D. The Female Sexual Function Index (FSFI): linguistic validation of the Italian version. J Sex Med. 2014 Feb;11(2):447-53. doi: 10.1111/jsm.12389. Epub 2013 Nov 13.
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• Background Bhatt A. Protocol deviation and violation. Perspect Clin Res. 2012 Jul;3(3):117. doi: 10.4103/2229-3485.100663. No abstract available.
• Background Ghooi RB, Bhosale N, Wadhwani R, Divate P, Divate U. Assessment and classification of protocol deviations. Perspect Clin Res. 2016 Jul-Sep;7(3):132-6. doi: 10.4103/2229-3485.184817.
• Background Fraser IS, Critchley HO, Munro MG, Broder M; Writing Group for this Menstrual Agreement Process. A process designed to lead to international agreement on terminologies and definitions used to describe abnormalities of menstrual bleeding. Fertil Steril. 2007 Mar;87(3):466-76. doi: 10.1016/j.fertnstert.2007.01.023.
• Background Fraser IS, Critchley HO, Munro MG, Broder M. Can we achieve international agreement on terminologies and definitions used to describe abnormalities of menstrual bleeding? Hum Reprod. 2007 Mar;22(3):635-43. doi: 10.1093/humrep/del478. Epub 2007 Jan 4.
• Background Fraser IS, Critchley HO, Broder M, Munro MG. The FIGO recommendations on terminologies and definitions for normal and abnormal uterine bleeding. Semin Reprod Med. 2011 Sep;29(5):383-90. doi: 10.1055/s-0031-1287662. Epub 2011 Nov 7.
• Cagnacci A, Grandi G, Capobianco G, Fulghesu AM, Morgante G, Biondelli V, Piccolo E, Casolati E, Mangrella M. Effects of a Monophasic Hormonal Contraceptive With Norgestimate+Ethinyl Estradiol on Menstrual Bleeding: Protocol and Design of a Multicenter, Prospective, Open-Label, Noncomparative Study in Italy. JMIR Res Protoc. 2025 Mar 31;14:e63683. doi: 10.2196/63683.

Drugs

Indications

No indication recorded.