Clinical trial NCT01650168: Prospective Controlled Cohort Study on the Safety of a Monophasic Oral Contraceptive Containing Nomegestrol Acetate (2.5mg) and 17ß-estradiol (1.5mg)
Official title: Prospective Controlled Cohort Study on the Safety of a Monophasic Oral Contraceptive Containing Nomegestrol Acetate (2.5mg) and 17ß-estradiol (1.5mg)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contraception
Keywords: NOMAC-E2
Nomegestrol acetate
Estradiol
Levonorgestrel
Safety
Lead sponsor: Center for Epidemiology and Health Research, Germany
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
name: Theramex
First posted: 2012-07-26
Enrollment: 101498
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women using oral contraceptives

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.

Eligibility criteria: 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

Primary outcomes:
measure: Venous thromboembolisms (VTE)
timeFrame: Within 2 years
Secondary outcomes:
measure: Arterial thromboembolisms (ATE)
timeFrame: Within 2 years
measure: Depressive disorders
timeFrame: Within 2 years
measure: Cholelithiasis
timeFrame: Within 2 years
measure: Inflammatory bowel disease
timeFrame: Within 2 years
measure: Short- and long-term fertility
timeFrame: Within 2 years
measure: Drug utilization pattern
timeFrame: Within 2 years
measure: Pregnancy outcomes
timeFrame: Within 2 years
measure: Weight change
timeFrame: Within 2 years
measure: General hepatobiliary disorders
timeFrame: Within 2 years
measure: Acne
timeFrame: Within 2 years
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Center for Epidemiology and Health Research Berlin
Study officials:
affiliation: Center for Epidemiology and Health Research, Berlin, Germany
name: Klaas Heinemann, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: