A randomized, open-label, comparative, multicenter trial to compare the effects on metabolic parameters of two NOMAC-E2 batches (pivotal phase III and commercial batch) and a monophasic COC containing 150 µg LNG and 30 µg EE (Phase III, Protocol No. P06447)

Phase 3

Completed

• Conditions: anticonceptie; contraception; preservatives

• Registration Number: NL-OMON34789
• Lead Sponsor: Schering-Plough

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 12 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

1. Each subject must be female and in good physical and mental health;
2. Each subject must be between 18 and 50 years (extremes included) of age at screening;
3. Each subject must have a body mass index between 17and 29 kg/m2 (extremes included)

Exclusion Criteria

1. Any contraindication for contraceptive steroids;
2. An abnormal cervical smear (i.e. dysplasia, cervical intraepithelial neoplasia (CIN), squamous intraepithelial lesion (SIL), carcinoma in situ, invasive carcinoma) at screening;
3. Present use or use within 2 months prior to screening of any hormonal treatment including sex hormones (other than contraceptives), insulin, thyroid and corticosteroid hormones (with the exception of local dermatological use)
4. Present use or use within 2 months prior to starting trial medication of hepatic-enzyme inducing medications that may affect the bioavailability of sex steroids, lipid-lowering drugs, or anticoagulants.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To compare the effects on the APC- (Activated Protein C) resistance ratio<br /><br>(ETP-[endogenous throbin potential] based) between the pivotal phase III<br /><br>NOMAC-E2 batch and a commercial NOMAC-E2 batch.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Compare effect on all other metabolic parameters of two NOMAC-E2 batches:<br /><br>hemostasis parameters, lipids and SHBG<br /><br><br /><br>Compare effect on metabolic parameters (as descibed above) between the two<br /><br>NOMAC-E2 batches and LNG-EE<br /><br><br /><br>General safety: decreased libido, depression/deppressed mood, altered mood,<br /><br>headache, migraine, nausea, acne, breast pain, withdrawal bleeding irregular,<br /><br>metrorrhagia, increased weight, routine lab parameters, vital signs, (serious)<br /><br>adverse events</p><br>