Clinical trial · Interventional
Contraceptive Pill and Hormonal Vaginal Ring in Women With Polycystic Ovary Syndrome
The Effects of Contraceptive Pill and Hormonal Vaginal Ring on Hormonal, Inflammatory and Metabolic Parameters in Women of Reproductive Age With Polycystic Ovary Syndrome (PCOS).
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adverse Effect of Oral Contraceptives, Sequela | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| oc:E-E-desogestrel/vaginal ring:E-E -ethonogestrel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Oral contraceptive pill
- interventionNames
- Drug: oc:E-E-desogestrel/vaginal ring:E-E -ethonogestrel
- type
- ACTIVE_COMPARATOR
- label
- Contraceptive ring
- interventionNames
- Drug: oc:E-E-desogestrel/vaginal ring:E-E -ethonogestrel
Primary outcomes (1)
- measure
- Change in Matsuda index during the oral contraceptive pill (E-E-desogestrel)/vaginal ring (E-E -ethonogestrel)
- timeFrame
- Change from baseline in Matsuda index at 59 weeks of treament
- description
- Calculation of the Matsuda index according to the following equation: \[10000 / √((fasting glucose x fasting insulin)x (Gmeanogtt x Imeanogtt))\]
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * women aged between 18 to 40 years * diagnosed PCOS (Rotterdam criteria) * healthy, no medications * no use of hormonal contraceptives or wash-out period of at least two months * no contraindications to hormonal contraception Exclusion Criteria: * regular smoking * excessive alcohol use * pregnancy or breastfeeding * oversensitivity to active ingredients * migraine with focal aura * severe or multiple risk factors to thrombosis * diagnosed or suspected cancer * diagnosed or suspected estrogen-dependent tumor * acute or chronic hepatocellular disease -related abnormal liver function * hepatic adenomas or carcinomas * undiagnosed abnormal vaginal bleeding
References
Publications (17)
- BACKGROUNDAcien 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. PMID 9130733
- BACKGROUNDAllen 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. PMID 16200842
- BACKGROUNDArmstrong 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. PMID 11161134
- BACKGROUNDBall 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. PMID 2335101
- BACKGROUNDBilgir 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. PMID 19602786
- BACKGROUNDCagnacci 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.