%0 Journal Article
%@ 1929-0748
%I JMIR Publications
%V 14
%N 
%P e63683
%T 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
%A Cagnacci,Angelo
%A Grandi,Giovanni
%A Capobianco,Giampiero
%A Fulghesu,Anna Maria
%A Morgante,Giuseppe
%A Biondelli,Vincenzo
%A Piccolo,Elena
%A Casolati,Elena
%A Mangrella,Mario
%+ Dipartimento di Neuroscienze, Riabilitazione, Oftalmologia e Scienze Materno Infantili, Istituto di Recerca e di Cura e Carattere Scientifico (IRCSS)-Ospedale San Martino, 10 Largo R Benzi, Genoa, 16132, Italy, 39 0103537728, angelo.cagnacci@unige.it
%K combined oral contraceptive
%K ethinyl estradiol
%K menstrual cycle
%K monophasic
%K norgestimate
%K hormonal contraceptive
%K menstrual health
%K Italy
%K women’s health
%K patient-reported outcomes
%K methodology
%K observational study
%K reproductive health
%K data analysis
%K assessment
%D 2025
%7 31.3.2025
%9 Protocol
%J JMIR Res Protoc
%G English
%X Background: Norgestimate (NGM) is a progestin with negligible androgenic activity that is available in combination with ethinyl estradiol (EE) as a monophasic combined oral contraceptive (COC). It has been more than 30 years since a clinical study evaluated the effects of monophasic NGM/EE on menstrual cycle characteristics in healthy women, and in the interim, there has been growing recognition that clinical trials of contraceptives should evaluate a wide range of potential positive and negative impacts for users. Objective: The aim of this study is to investigate menstrual cycle control during the use of a monophasic COC formulation containing NGM 0.25 mg and EE 0.035 mg (Effimia; Italfarmaco SpA), using established methodologies as well as patient-reported outcomes. Methods: This is a prospective observational study being undertaken in a target population of 228 healthy Italian women aged 18-35 years who are starting oral contraception for the first time or switching from another COC. The participants are asked to complete a diary for 6 cycles recording information about their menstrual cycles (frequency, duration, regularity, estimated flow volume, and breakthrough bleeding), any unscheduled bleeding, and an evaluation of dysmenorrhea, using a 100-mm visual analog scale from 0=no pain to 100=very severe pain, and any adverse events. Compliance is assessed after 3 and 6 months via returned medication. The primary end point is the change from baseline in the rate of intermenstrual bleeding during the sixth cycle. At baseline, 3 months, and 6 months, acne will also be assessed using the Global Acne Grading Scale, and participants will complete a Profile of Mood State to assess premenstrual syndrome and the Female Sexual Function Index to evaluate the quality of their sex life. A subgroup of 28 participants at 1 site (Genoa) is also providing a blood sample for the assessment of metabolic, endocrine, and coagulation parameters. Results: Study enrollment began in July 2023 and is expected to be complete by December 2024. Data analysis is expected to be complete by October 2025. Conclusions: This study into the effects of monophasic NGM/EE 0.25/0.035 mg on menstrual characteristics in healthy Italian women will provide up-to-date data on these effects and includes assessments of a range of other parameters, such as acne severity and patient-reported outcomes, in line with recent international consensus recommendations. Trial Registration: ClinicalTrials.gov NCT06067256; https://clinicaltrials.gov/study/NCT06067256 and EudraCT 2021-003027-15; https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-003027-15/IT International Registered Report Identifier (IRRID): DERR1-10.2196/63683 
%R 10.2196/63683
%U https://www.researchprotocols.org/2025/1/e63683
%U https://doi.org/10.2196/63683