Prospective Controlled Cohort Study on the Safety of a Monophasic Oral Contraceptive Containing Nomegestrol Acetate (2.5mg) and 17ß-estradiol (1.5mg)

Contraception Clinical Trial

— PRO-E2  

Official title:

Prospective Controlled Cohort Study on the Safety of a Monophasic Oral Contraceptive Containing Nomegestrol Acetate (2.5mg) and 17ß-estradiol (1.5mg)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01650168
• Other study ID #: ZEG2013_08
• Status: Completed
• Start date: July 2012
• Est. completion date: December 2020

Study information

• Verified date: July 2021
• Source: Center for Epidemiology and Health Research, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study compares the risks of short- and long-term use of NOMAC-E2 (containing a fixed dose of nomegestrol acetate and estradiol) compared with levonorgestrel-containing combined oral contraceptives (COC-LNG) in a study population representative of the actual users of the individual preparations.

Description:

NOMAC-E2 is a novel monophasic oral contraceptive containing a fixed dose of nomegestrol acetate (2.5mg) and 17ß-estradiol (1.5mg) which is taken for 24 days followed by 4 days of placebo. The most relevant adverse clinical outcome that has been linked to the use of COCs is venous thromboembolism (VTE). Data from randomized clinical trials did not show any serious health concerns for NOMAC-E2. However, the statistical power to detect rare adverse events is limited in these studies.

PRO-E2 is a large, prospective, controlled, long-term active surveillance study to investigate the safety of NOMAC-E2 with regard to the outcomes of interest. This study follows the European Active Surveillance (EURAS) design methodology with some modifications due to country- and product-specific characteristics. The outcomes of interest will be validated via the attending physicians. A multi-faceted follow-up procedure will ensure a low loss to follow-up rate. This study will involve women from Europe and Australia who will be followed for up to 2 years. Data analysis will include multivariable techniques such as Cox regression.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101498
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• First ever user of a COC ("starter")

• User who restarts hormonal contraceptive use with a COC (same COC as before or a new COC) after an intake break of at least two months ("restarters")

• Women willing to participate in the active surveillance

Exclusion Criteria:

• Women who do not understand the major aspects of the study

Related Conditions & MeSH terms

• Contraception

Locations

Country	Name	City	State
Germany	Center for Epidemiology and Health Research Berlin	Berlin

Sponsors (3)

Lead Sponsor	Collaborator
Center for Epidemiology and Health Research, Germany	Merck Sharp & Dohme Corp., Theramex

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Venous thromboembolisms (VTE)		Within 2 years
Secondary	Arterial thromboembolisms (ATE)		Within 2 years
Secondary	Depressive disorders		Within 2 years
Secondary	Cholelithiasis		Within 2 years
Secondary	Inflammatory bowel disease		Within 2 years
Secondary	Short- and long-term fertility		Within 2 years
Secondary	Drug utilization pattern		Within 2 years
Secondary	Pregnancy outcomes		Within 2 years
Secondary	Weight change		Within 2 years
Secondary	General hepatobiliary disorders		Within 2 years
Secondary	Acne		Within 2 years