Effects on Hemostasis, Lipids, Carbohydrate Metabolism, Adrenal & Thyroid Function of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing LNG-EE (292004)(COMPLETED)(P05764)
Summary
The primary purpose of this study is to evaluate the effects of the combined oral contraceptive (COC) NOMAC-E2 on hemostasis, lipids, carbohydrate metabolism, adrenal function, and thyroid function.
Timeline
- Start
- 2006-10
- Primary completion
- 2008-01
- Completion
- 2008-01
Outcome
Mixed primary results
registry MEAN NOMAC-E2: Cycle 6 (n=53 NOMAC-E2; n=51 LNG-EE): 1.65 (Standard Deviation 0.34) mmol/L NCT00511355 ↗
registry MEAN LNG-EE: Cycle 6 (n=53 NOMAC-E2; n=51 LNG-EE): 1.41 (Standard Deviation 0.26) mmol/L NCT00511355 ↗
registry analysis (unspecified test); NOMAC-E2 vs LNG-EE; p <.0001; Cochran-Mantel-Haenszel; note: No correction for multiple testing was made. NCT00511355 ↗
paper Lipids were essentially unchanged with NOMAC/E2, whereas with LNG/EE high-density lipoprotein cholesterol decreased PMID 22066891 ↗
registry MEAN NOMAC-E2: Cycle 6 (n=53 NOMAC-E2; n=51 LNG-EE): 4.51 (Standard Deviation 0.83) mmol/L NCT00511355 ↗
registry MEAN LNG-EE: Cycle 6 (n=53 NOMAC-E2; n=51 LNG-EE): 4.48 (Standard Deviation 0.75) mmol/L NCT00511355 ↗
registry analysis (unspecified test); NOMAC-E2 vs LNG-EE; p = 0.6886; Cochran-Mantel-Haenszel; note: No correction for multiple testing was made. NCT00511355 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Estradiol | Other / unclassified | 1.5 mg | Oral |
| Comparator | Levonorgestrel | Small molecule | 150 ug | Oral |
| Subject | Nomegestrol Acetate | Small molecule | 2.5 mg | Oral |
| Comparator | ethinyl estradiol | Small molecule | 30 ug | Oral |
Indications
No indication recorded.