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Metabolic and haemostatic effects of estradiol valerate/dienogest, a novel oral contraceptive: a randomized, open-label, single-centre study.
Clin Drug Investig. 2011; 31(8):573-584.CD

Abstract

BACKGROUND AND OBJECTIVE

The hormonal components of combined oral contraceptives (COCs) have various metabolic and haemostatic effects. The objective of this study was to compare the metabolic and haemostatic effects of a novel COC comprising estradiol valerate/dienogest (E(2)V/DNG) with ethinylestradiol/levonorgestrel (EE/LNG).

METHODS

In a randomized, open-label study conducted in Germany over seven cycles, healthy women aged 18-50 years received E(2)V/DNG (E(2)V 3 mg on days 1-2, E(2)V 2 mg/DNG 2 mg on days 3-7, E(2)V 2 mg/DNG 3 mg on days 8-24, E(2)V 1 mg on days 25-26, placebo on days 27-28; n = 30) or EE/LNG (EE 0.03 mg/LNG 0.05 mg on days 1-6, EE 0.04 mg/LNG 0.075 mg on days 7-11, EE 0.03 mg/LNG 0.125 mg on days 12-21, placebo on days 22-28; n = 28). The primary variables were the mean intraindividual relative changes from baseline to cycle 7 in high-density lipoprotein (HDL) and low-density lipoprotein (LDL) cholesterol levels. Changes in other lipid parameters, haemostatic parameters, sex hormone-binding globulin (SHBG), cortisol-binding globulin (CBG), carbohydrate metabolism parameters, blood pressure and body weight were also assessed.

RESULTS

Mean ± SD HDL cholesterol increased by 7.9% ± 21.8% with E(2)V/DNG and decreased by 2.3% ± 14.4% with EE/LNG. Mean ± SD LDL cholesterol decreased by 6.5% ± 15.9% with E(2)V/DNG and by 3.0% ± 17.4% with EE/LNG. Mean ± SD prothrombin fragment 1 + 2 and D-dimer levels remained essentially unchanged in the E(2)V/DNG group (-0.6% ± 30.3% and -2.1% ± 43.5%, respectively), but increased in the EE/LNG group (by 117.3% ± 358.0% and 62.9% ± 99.5%, respectively). Changes in other hepatic-induced parameters (SHBG, CBG) and carbohydrate metabolism were generally less pronounced with E(2)V/DNG versus EE/LNG. Body weight and blood pressure remained stable throughout the study in both treatment groups. Both formulations were well tolerated, with no serious adverse events reported.

CONCLUSION

E(2)V/DNG had a minimal impact on metabolic and haemostatic parameters, and a more favourable effect than EE/LNG on lipid markers.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT00185224.

Authors+Show Affiliations

Laboratorium fuer Klinische Forschung, Kiel, Germany.Bayer HealthCare Pharmaceuticals, Müllerstraβe 178, 13342, Berlin, Germany.Bayer HealthCare Pharmaceuticals, Müllerstraβe 178, 13342, Berlin, Germany. susanne.parke@bayer.com.Bayer HealthCare Pharmaceuticals, Müllerstraβe 178, 13342, Berlin, Germany.

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

21721593

Citation

Junge, Wolfgang, et al. "Metabolic and Haemostatic Effects of Estradiol Valerate/dienogest, a Novel Oral Contraceptive: a Randomized, Open-label, Single-centre Study." Clinical Drug Investigation, vol. 31, no. 8, 2011, pp. 573-584.
Junge W, Mellinger U, Parke S, et al. Metabolic and haemostatic effects of estradiol valerate/dienogest, a novel oral contraceptive: a randomized, open-label, single-centre study. Clin Drug Investig. 2011;31(8):573-584.
Junge, W., Mellinger, U., Parke, S., & Serrani, M. (2011). Metabolic and haemostatic effects of estradiol valerate/dienogest, a novel oral contraceptive: a randomized, open-label, single-centre study. Clinical Drug Investigation, 31(8), 573-584. https://doi.org/10.2165/11590220-000000000-00000
Junge W, et al. Metabolic and Haemostatic Effects of Estradiol Valerate/dienogest, a Novel Oral Contraceptive: a Randomized, Open-label, Single-centre Study. Clin Drug Investig. 2011;31(8):573-584. PubMed PMID: 21721593.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Metabolic and haemostatic effects of estradiol valerate/dienogest, a novel oral contraceptive: a randomized, open-label, single-centre study. AU - Junge,Wolfgang, AU - Mellinger,Uwe, AU - Parke,Susanne, AU - Serrani,Marco, PY - 2011/7/5/entrez PY - 2011/7/5/pubmed PY - 2011/11/2/medline SP - 573 EP - 584 JF - Clinical drug investigation JO - Clin Drug Investig VL - 31 IS - 8 N2 - BACKGROUND AND OBJECTIVE: The hormonal components of combined oral contraceptives (COCs) have various metabolic and haemostatic effects. The objective of this study was to compare the metabolic and haemostatic effects of a novel COC comprising estradiol valerate/dienogest (E(2)V/DNG) with ethinylestradiol/levonorgestrel (EE/LNG). METHODS: In a randomized, open-label study conducted in Germany over seven cycles, healthy women aged 18-50 years received E(2)V/DNG (E(2)V 3 mg on days 1-2, E(2)V 2 mg/DNG 2 mg on days 3-7, E(2)V 2 mg/DNG 3 mg on days 8-24, E(2)V 1 mg on days 25-26, placebo on days 27-28; n = 30) or EE/LNG (EE 0.03 mg/LNG 0.05 mg on days 1-6, EE 0.04 mg/LNG 0.075 mg on days 7-11, EE 0.03 mg/LNG 0.125 mg on days 12-21, placebo on days 22-28; n = 28). The primary variables were the mean intraindividual relative changes from baseline to cycle 7 in high-density lipoprotein (HDL) and low-density lipoprotein (LDL) cholesterol levels. Changes in other lipid parameters, haemostatic parameters, sex hormone-binding globulin (SHBG), cortisol-binding globulin (CBG), carbohydrate metabolism parameters, blood pressure and body weight were also assessed. RESULTS: Mean ± SD HDL cholesterol increased by 7.9% ± 21.8% with E(2)V/DNG and decreased by 2.3% ± 14.4% with EE/LNG. Mean ± SD LDL cholesterol decreased by 6.5% ± 15.9% with E(2)V/DNG and by 3.0% ± 17.4% with EE/LNG. Mean ± SD prothrombin fragment 1 + 2 and D-dimer levels remained essentially unchanged in the E(2)V/DNG group (-0.6% ± 30.3% and -2.1% ± 43.5%, respectively), but increased in the EE/LNG group (by 117.3% ± 358.0% and 62.9% ± 99.5%, respectively). Changes in other hepatic-induced parameters (SHBG, CBG) and carbohydrate metabolism were generally less pronounced with E(2)V/DNG versus EE/LNG. Body weight and blood pressure remained stable throughout the study in both treatment groups. Both formulations were well tolerated, with no serious adverse events reported. CONCLUSION: E(2)V/DNG had a minimal impact on metabolic and haemostatic parameters, and a more favourable effect than EE/LNG on lipid markers. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00185224. SN - 1179-1918 UR - https://www.unboundmedicine.com/medline/citation/21721593/Metabolic_and_haemostatic_effects_of_estradiol_valerate/dienogest_a_novel_oral_contraceptive:_a_randomized_open_label_single_centre_study_ L2 - https://dx.doi.org/10.2165/11590220-000000000-00000 DB - PRIME DP - Unbound Medicine ER -