Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-30 @ 4:20 PM
Study NCT ID:
NCT01650168
Status:
COMPLETED
Last Update Posted:
2021-07-28
First Post:
2012-07-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Controlled Cohort Study on the Safety of a Monophasic Oral Contraceptive Containing Nomegestrol Acetate (2.5mg) and 17ß-estradiol (1.5mg)
Sponsor:
Center for Epidemiology and Health Research, Germany
Organization:
Study Overview
Official Title:
Prospective Controlled Cohort Study on the Safety of a Monophasic Oral Contraceptive Containing Nomegestrol Acetate (2.5mg) and 17ß-estradiol (1.5mg)
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRO-E2
Brief 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.
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: