NCT06067256

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

A Multicentre, Prospective, Open-label, Non-comparative Study to Evaluate Menstrual Bleeding Typology, Tolerability, and Compliance During a Monophasic Hormonal Contraceptive Treatment With Norgestimate + Ethinylestradiol in Italy.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 228 (estimated)
• Sponsor: Italfarmaco · Industry
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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.

Conditions

• Contraception

Interventions

Type	Name	Description
DRUG	Female Contraceptive	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.

Timeline

• Start date: 2023-07-20
• Primary completion: 2023-12-01
• Completion: 2024-06-01
• First posted: 2023-10-04
• Last updated: 2023-10-04

Locations

1 site across 1 country: Italy