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

NCT06067256 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 228

Last updated 2023-10-04

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Italfarmaco

    lead INDUSTRY

Principal Investigators

  • Angelo Cagnacci, MD · IRCCS Ospedale Policlinico San Martino, Clinica Ostetrica e Ginecologica

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-20
Primary Completion
2023-12-31
Completion
2024-06-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06067256 on ClinicalTrials.gov