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A Multicentre, Prospective, Open-label, Non-comparative Study - Trial NCT06067256

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.

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NCT06067256
Phase 4
Recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06067256
View on ClinicalTrials.gov
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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.

Study Focus

Contraception

Female Contraceptive

Interventional

drug

Sponsor & Location

Italfarmaco

San Martino, Italy

Timeline & Enrollment

Phase 4

Jul 20, 2023

Jun 01, 2024

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 Effimiaยฎ (NGM250 + EE35) in a population of women residing in Italy.

ICD-10 Classifications

Contraceptive management
Oral contraceptives
Other contraceptive management
General counselling and advice on contraception
Personal history of contraception

Data Source

ClinicalTrials.gov

NCT06067256

Non-Device Trial