drugset / Trial / NCT01588873
Contraceptive Pill and Hormonal Vaginal Ring in Women With Polycystic Ovary Syndrome
RandomizedParallel-groupOpen-labelTreatment
Summary
The main aims of this study are: * to investigate and compare the effects of long lasting use (59 weeks) of vaginal and oral contraceptives on androgen secretion, insulin and glucose metabolism, lipid profile, and serum levels of SHBG and hs-CRP in women with PCOS. * to compare the metabolic effects of oral and vaginal combined contraceptives and to find out whether oral or transvaginal contraceptive can be recommended to a particular group of women, for example in women with increased metabolic risks. * to clarify whether the unfavourable effects of combined contraceptives diminish with time (after use of one year).
Timeline
- Start
- 2012-04
- Primary completion
- 2018-12
- Completion
- 2019-12
Publications
- Background Acien P, Mauri M, Gutierrez M. Clinical and hormonal effects of the combination gonadotrophin-releasing hormone agonist plus oral contraceptive pills containing ethinyl-oestradiol (EE) and cyproterone acetate (CPA) versus the EE-CPA pill alone on polycystic ovarian disease-related hyperandrogenisms. Hum Reprod. 1997 Mar;12(3):423-9. doi: 10.1093/humrep/12.3.423.
- Background Allen HF, Mazzoni C, Heptulla RA, Murray MA, Miller N, Koenigs L, Reiter EO. Randomized controlled trial evaluating response to metformin versus standard therapy in the treatment of adolescents with polycystic ovary syndrome. J Pediatr Endocrinol Metab. 2005 Aug;18(8):761-8. doi: 10.1515/jpem.2005.18.8.761.
- Background Armstrong VL, Wiggam MI, Ennis CN, Sheridan B, Traub AI, Atkinson AB, Bell PM. Insulin action and insulin secretion in polycystic ovary syndrome treated with ethinyl oestradiol/cyproterone acetate. QJM. 2001 Jan;94(1):31-7. doi: 10.1093/qjmed/94.1.31.
- Background Ball MJ, Ashwell E, Jackson M, Gillmer MD. Comparison of two triphasic contraceptives with different progestogens: effects on metabolism and coagulation proteins. Contraception. 1990 Apr;41(4):363-76. doi: 10.1016/0010-7824(90)90036-u.
- Background Bilgir O, Kebapcilar L, Taner C, Bilgir F, Kebapcilar A, Bozkaya G, Yildiz Y, Yuksel A, Sari I. The effect of ethinylestradiol (EE)/cyproterone acetate (CA) and EE/CA plus metformin treatment on adhesion molecules in cases with polycystic ovary syndrome (PCOS). Intern Med. 2009;48(14):1193-9. doi: 10.2169/internalmedicine.48.2177. Epub 2009 Jul 15.
- Background Cagnacci A, Paoletti AM, Renzi A, Orru M, Pilloni M, Melis GB, Volpe A. Glucose metabolism and insulin resistance in women with polycystic ovary syndrome during therapy with oral contraceptives containing cyproterone acetate or desogestrel. J Clin Endocrinol Metab. 2003 Aug;88(8):3621-5. doi: 10.1210/jc.2003-030328.
- Background Carranza-Lira S, Magana-Padilla NR. [Ultrasonographic and lipid changes in polycystic ovary syndrome according to the type of treatment ]. Ginecol Obstet Mex. 2002 Jun;70:285-8. Spanish.
- Background Charitidou C, Farmakiotis D, Zournatzi V, Pidonia I, Pegiou T, Karamanis N, Hatzistilianou M, Katsikis I, Panidis D. The administration of estrogens, combined with anti-androgens, has beneficial effects on the hormonal features and asymmetric dimethyl-arginine levels, in women with the polycystic ovary syndrome. Atherosclerosis. 2008 Feb;196(2):958-65. doi: 10.1016/j.atherosclerosis.2007.03.002. Epub 2007 Apr 6.
- Background Chasan-Taber L, Willett WC, Stampfer MJ, Hunter DJ, Colditz GA, Spiegelman D, Manson JE. A prospective study of oral contraceptives and NIDDM among U.S. women. Diabetes Care. 1997 Mar;20(3):330-5. doi: 10.2337/diacare.20.3.330.
- Background Chen MJ, Yang WS, Chen HF, Kuo JJ, Ho HN, Yang YS, Chen SU. Increased follistatin levels after oral contraceptive treatment in obese and non-obese women with polycystic ovary syndrome. Hum Reprod. 2010 Mar;25(3):779-85. doi: 10.1093/humrep/dep459. Epub 2010 Jan 20.
- Background Cibula D, Sindelka G, Hill M, Fanta M, Skrha J, Zivny J. Insulin sensitivity in non-obese women with polycystic ovary syndrome during treatment with oral contraceptives containing low-androgenic progestin. Hum Reprod. 2002 Jan;17(1):76-82. doi: 10.1093/humrep/17.1.76.
- Background Cibula D, Fanta M, Vrbikova J, Stanicka S, Dvorakova K, Hill M, Skrha J, Zivny J, Skrenkova J. The effect of combination therapy with metformin and combined oral contraceptives (COC) versus COC alone on insulin sensitivity, hyperandrogenaemia, SHBG and lipids in PCOS patients. Hum Reprod. 2005 Jan;20(1):180-4. doi: 10.1093/humrep/deh588. Epub 2004 Dec 2.
- Background Costello MF, Shrestha B, Eden J, Johnson NP, Sjoblom P. Metformin versus oral contraceptive pill in polycystic ovary syndrome: a Cochrane review. Hum Reprod. 2007 May;22(5):1200-9. doi: 10.1093/humrep/dem005. Epub 2007 Jan 29.
- Background Creatsas G, Koliopoulos C, Mastorakos G. Combined oral contraceptive treatment of adolescent girls with polycystic ovary syndrome. Lipid profile. Ann N Y Acad Sci. 2000;900:245-52. doi: 10.1111/j.1749-6632.2000.tb06236.x.
- Background Duleba AJ, Banaszewska B, Spaczynski RZ, Pawelczyk L. Simvastatin improves biochemical parameters in women with polycystic ovary syndrome: results of a prospective, randomized trial. Fertil Steril. 2006 Apr;85(4):996-1001. doi: 10.1016/j.fertnstert.2005.09.030. Epub 2006 Mar 9.
- Background Dunaif A, Segal KR, Futterweit W, Dobrjansky A. Profound peripheral insulin resistance, independent of obesity, in polycystic ovary syndrome. Diabetes. 1989 Sep;38(9):1165-74. doi: 10.2337/diab.38.9.1165.
- Background Ehrmann DA. Polycystic ovary syndrome. N Engl J Med. 2005 Mar 24;352(12):1223-36. doi: 10.1056/NEJMra041536. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Desogestrel | Small molecule | 150 ug | Oral |
| Comparator | Etonogestrel | Unknown | 11.7 mg | Other |
| Comparator | ethinyl estradiol | Small molecule | 20 ug | Other |
| Comparator | ethinyl estradiol | Small molecule | 2.7 mg | Other |
Indications
No indication recorded.