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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
228
Effimia® exerts its action by means of a gonadotropin suppression mechanism through the estrogenic and progestin action exerted by EE and NGM. The contraceptive effect of Effimia® is based on the interaction of various factors, the most important of which consist of ovulation inhibition and endometrial modifications.
IRCCS Ospedale Policlinico
San Martino, Genova, Italy
RECRUITINGCycle control evaluation parameter
breakthrough bleeding (bleeding and/or spotting between cyclically regular onset of menses) by calculating the intermenstrual spotting occurrence rate at sixth cycle only (value to be intended as not cumulative with values from the other 5 cycles taking place during the whole study period). A comparison within group will be performed at V3 with respect to Baseline (V1)
Time frame: 180 days
Cycle control evaluation parameters
frequency, duration, regularity, flow volume (subject determined), unscheduled bleeding. A comparison within group will be performed at V2 and V3 with respect to Baseline (V1).
Time frame: 180 days
Global Acne Grading System (GAGS).
A comparison within group will be performed at V2 and V3 with respect to Baseline (V1).
Time frame: 180 days
Profile of Mood State (POMS).
A comparison within group will be performed at V2 and V3 with respect to Baseline (V1).
Time frame: 180 days
Female Sexual Function Index (FSFI).
A comparison within group will be performed at V2 and V3 with respect to Baseline (V1).
Time frame: 180 days
Dysmenorrhea - VAS scale.
A comparison within group will be performed at V2 and V3 with respect to Baseline (V1)
Time frame: 180 days
Compliance
Adherence to treatment
Time frame: 180 days
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Contraception failure rate during the 6-month treatment
the contraception failure rate is defined as the proportion of women who will become pregnant during the study period. The reasons for any contraception failure occurrence will be identified and listed (e.g., discontinuation or poor compliance).
Time frame: 180 days
Metabolic and hormonal parameters
blood lipid and glucose parameters (total cholesterol, High Density Lipoprotein - Cholesterol HDL-C, Low Density Lipoprotein - Cholesterol LDL-C, triglycerides, total testosterone, dehydroepiandrosterone - DHEAS, androstenedione, glucose, insulin, Sex Hormone Binding Globulin - SHBG) and hyperandrogenism (Free Androgenicity Index - FAI) - only in a subgroup of 28 subjects recruited only in the centre of Genova. They will be evaluated in comparison with Baseline (V1).
Time frame: 180 days