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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.
Italfarmaco·Phase 4·ClinicalTrials.gov·drugRecruiting
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Study focus
Disease/Condition
Contraception
Drug/Device/Intervention
Female Contraceptive
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Italfarmaco
Location
San Martino, Italy
Timeline & enrollment
Phase
Phase 4
Start date
Jul 20, 2023
End date
Jun 01, 2024
Enrollment
228 participants
Primary outcome

Cycle control evaluation parameter

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.

ICD-10 classifications
Contraceptive managementOral contraceptivesOther contraceptive managementGeneral counselling and advice on contraceptionPersonal history of contraception
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06067256
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06067256 through Pure Global AI's free database. This Phase 4 trial is sponsored by Italfarmaco and is currently Recruiting. The study focuses on Contraception. Target enrollment is 228 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.