Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jun 26, 2024
Date Accepted: Jan 20, 2025
Effects of a monophasic hormonal contraceptive with norgestimate + ethinylestradiol on menstrual bleeding: Protocol and design of a multicenter, prospective, open-label, non-comparative study in Italy
ABSTRACT
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 use of a monophasic COC formulation containing NGM 0.25 mg and EE 0.035 mg (Effimia®; Italfarmaco SpA, Milan, Italy), using established methodologies as well as patient-reported outcomes (PROs).
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 record 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 (VAS) from 0 (no pain) to 100 (very severe pain), and any adverse events (AEs) in a diary for six cycles. Compliance is assessed after 3 and 6 months via returned medication. The primary endpoint 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 (GAGS), and participants will complete a Profile of Mood State (POMS) to assess premenstrual syndrome and the Female Sexual Function Index (FSFI) to evaluate the quality of their sex life. A subgroup of 28 participants at one site (Genova) are also providing a blood sample for the assessment of metabolic, endocrine and coagulation parameters.
Results:
Study enrolment 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 PROs, in line with recent international consensus recommendations. Clinical Trial: clinicaltrials.gov NCT06067256; EudraCT 2021-003027-15
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