The bioequivalence of the contraceptive steroids ethinylestradiol and drospirenone is not affected by co-administration of dehydroepiandrosterone

European Journal of Contraception and Reproductive Health Care

Volumn 18, Issue 3, 2013, Pages 206-214

  Zimmerman, Yvette ^a   Wouters, Wout ^a   Coelingh Bennink, Herjan J T ^a  

^a Pantarhei Bioscience   (Netherlands)

Author keywords

Bioequivalence; DHEA administration; Drospirenone; Ethinylestradiol; Oral contraception

Indexed keywords

DROSPIRENONE; DROSPIRENONE PLUS ETHINYLESTRADIOL; ETHINYLESTRADIOL; ORAL CONTRACEPTIVE AGENT; PLACEBO; PRASTERONE;

ADULT; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CONTROLLED STUDY; CROSSOVER PROCEDURE; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG EFFECT; DRUG ELIMINATION; DRUG HALF LIFE; FEMALE; HORMONAL CONTRACEPTION; HUMAN; MAXIMUM PLASMA CONCENTRATION; MORNING DOSAGE; NORMAL HUMAN; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TIME TO MAXIMUM PLASMA CONCENTRATION;

ADULT; ANDROSTENES; CONTRACEPTIVES, ORAL, COMBINED; CROSS-OVER STUDIES; DEHYDROEPIANDROSTERONE; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; ETHINYL ESTRADIOL; FEMALE; HUMANS; REPRODUCTIVE CONTROL AGENTS; THERAPEUTIC EQUIVALENCY;

EID: 84877823286     PISSN: 13625187     EISSN: 14730782     Source Type: Journal    
DOI: 10.3109/13625187.2013.777831     Document Type: Article

References (24)

1. Wiegratz I , Kutschera E , Lee J , e t a l. Effect of four different oral contraceptives on various sex hormones and serum-binding globulins . Contraception 2003 ; 67 : 25-32 . (Pubitemid 36084284)
2. Aden U, Jung-Hoffmann C, Kuhl H. A randomized cross-over study on various hormonal parameters of two triphasic oral contraceptives . Contraception 1998 ; 58 : 75-81 . (Pubitemid 28449360)
3. Åg ren U M, Anttila M , Mä epä ä-Liukko K , et a l. Effects of a monophasic combined oral contraceptive containing nomegestrol acetate and 17 ß-oestradiol in comparison to one containing levonorgestrel and ethinylestradiol on markers of endocrine function . Eur J Contracept Reprod Health Care 2011 ; 16 : 458-67 .
4. Fern M, Rose D , Fern E . Effect of oral contraceptives on plasma androgenic steroids and their precursors . Obstet Gynecol 1978 ; 51 : 541-4 . (Pubitemid 8314439)
5. Coenen C , Thomas C , Borm G , et a l. Changes in androgens during treatment with four low-dose contraceptives . Contraception 1996 ; 53 : 171-6 . (Pubitemid 26082289)
6. Van der Vange N, Blankenstein M, Kloosterboer H, e t al. Effects of seven low-dose combined oral contraceptives on sex hormone binding globulin, corticosteroid binding globulin, total and free testosterone . Contraception 1990 ; 41 : 345-52 . (Pubitemid 20134343)
7. Greco T, Graham C, Bancroft J, et al. The effects of oral contraceptives on androgen levels and their relevance to premenstrual mood and sexual interest: A comparison of two triphasic formulations containing norgestimate and either 35 or 25 g of ethinyl estradiol. Contraception 2007 ; 76 : 8-17 . (Pubitemid 46950885)
8. Burger H G. Androgen production in women. Fertil Steril 2002 ; 77(Suppl. 4) : S3-S5 . (Pubitemid 34465837)
9. Speroff L, Fritz M. Clinical gynecologic endocrinology and infertility . Philadelphia, PA: Lippincott, Williams & Wilkins 2005 : 515 .
10. Boyd R A, Z egarac E A , Posvar E L , Flack M R. Minimal androgenic activity of a new oral contraceptive containing norethindrone acetate and graduated doses of ethinyl estradiol . Contraception 2001 ; 63 : 71-6 . (Pubitemid 32268679)
11. Åg ren U M, Anttila M , Mä enp ä ä-Liukko K , et a l. Effects of a monophasic combined oral contraceptive containing nomegestrol acetate and 17 ß-oestradiol compared with one containing levonorgestrel and ethinylestradiol on haemostasis, lipids and carbohydrate metabolism . Eur J Contracept Reprod Health Care 2011 ; 16 : 444-57 .
12. van Kammen E , Thijssen J HH, Rademaker B , Schwarz F . The infl uence of hormonal contraceptives on sex hormone binding globulin (SHBG) capacity . Contraception 1975 ; 11 : 53-9 .
13. Odlind V, Milson I , Persson I , Victor A. Can changes in sex hormone binding globulin predict the risk of venous thromboembolism with combined oral contraceptive pills? Acta Obstet Gynecol Scand 2002 ; 81 : 482-90 .
14. Hammond G L, Langley M S, Robinson P A, et a l. Serum steroid binding protein concentrations, distributions of progestogens, and bioavailability of testosterone during treatment with contraceptives containing desogestrel or levonorgestrel . Fertil Steril 1984 ; 42 : 44-51 . (Pubitemid 14086149)
15. Bachmann G, Bancroft J, Braunstein G, e t al. Female androgen insuffi ciency: The Princeton consensus statement on defi nition, classifi cation, and assessment . Fertil Steril 2002 ; 77 : 660-5 . (Pubitemid 34275339)
16. Traish A , Guay A , Spark R , the Testosterone Therapy in Women Study Group . Are the Endocrine Society ' s clinical practice guidelines on androgen therapy in women misguided? A commentary. J Sex Med 2007 ; 4 : 1223-35 . (Pubitemid 47337665)
17. Arlt W , J ustl H-G, C allies F , e t a l. O ral dehydroepiandrosterone for adrenal androgen replacement: Pharmacokinetics and peripheral conversion to androgens and estrogens in young healthy females after dexamethasone suppression . J Clin Endocrinol Metab 1998 ; 83 : 1928-34 . (Pubitemid 28496318)
18. Meno-Tetang G , Blum R , Schwartz K , Jusko W . Effects of oral prasterone (dehydroepiandrosterone) on singledose pharmacokinetics or oral prednisone and cortisol suppression in normal women . J Clin Pharmacol 2001 ; 41 : 1195-205 . (Pubitemid 32983218)
19. Morales A, Nolan J , Nelson J , Yen S . Effects of replacement dose of dehydroepiandrosterone in men and women of advancing age . J Clin Endocrinol Metab 1994 ; 78 : 1360-7 . (Pubitemid 24181005)
20. Legrain S, Massien C, Lahlou N, et al. Dehydroepiandrosterone replacement administration: Pharmacokinetic and pharmacodynamic studies in healthy elderly subjects . J Clin Endocrinol Metab 2000 ; 85 : 3208-17 .
21. Baulieu E-E , Thomas G, Legrain S, et al. Dehydroepiandrosterone (DHEA), DHEA sulfate, and aging: Contribution of the DHEAge Study to a sociobiomedical issue . PNAS 2000 ; 97 : 4279-84 . (Pubitemid 30226124)
22. Blode H , Wuttke W , Loock W , et a l. A 1-year pharmacokinetic investigation of a novel oral contraceptive containing drospirenone in healthy female volunteers . Eur J Contracept Reprod Health Care 2000 ; 5 : 256-64 . (Pubitemid 32165464)
23. Duijkers I , Klipping C, Grob P, Korver T . Effects of a monophasic combined oral contraceptive containing nomegestrol acetate and 17 ß-oestradiol on ovarian function in comparison to a monophasic combined oral contraceptive containing drospirenone and ethinylestradiol . Eur J Contracept Reprod Health Care 2010 ; 15 : 314-25 .
24. van der Spuy Z M, Sohnius U , Pienaar C A, Schall R. Gonadotropin and estradiol secretion during the week of placebo therapy in oral contraceptive pill users . Contraception 1990 ; 42 : 597-609 .