The contraceptive vaginal ring in women with renal and liver transplantation: analysis of preliminary results.
BACKGROUND
Vaginal administration seems to be the best route to achieve steady and precise doses of contraceptive hormones, resulting in stable serum concentrations and low exposure. The aim of this study was to evaluate the contraceptive efficacy, cycle control, tolerability and acceptability of a contraceptive vaginal ring (NuvaRing) in renal and liver transplant recipients.


METHODS
Renal or liver transplant recipients, asking for contraception, were enrolled into the study. The duration of treatment was 12 cycles, with each vaginal ring releasing an average of 120 mg etonogestrel and 15 mg ethinylestradiol daily. Study visits were scheduled at screening, in the first week following cycles 3, 6, and 12 (172 cycles).


RESULTS
Among 17 females included into the study: were 9 renal (mean age, 30 +/- 7.2 years) and 8 liver transplant recipients (mean age, 32.6 +/- 6.6 years). At the onset of therapy all patients showed at least 6 months of stable graft function with no signs of allograft rejection. The mean posttransplant follow-up was 4 +/- 3.6 and 5.3 +/- 2.1 years for women with renal and hepatic transplantations respectively (P = NS). The immunosuppressive therapy was not changed for any patient. We demonstrated good cycle control: 162 cycles did not exhibit any bleeding; 7 cycles, only spotting episodes, whereas 2 cycles had 1 bleeding episode during the ring period. The estrogen-related adverse events (nausea and breast tenderness) were reported in 2 patients. One patient experienced significant bleeding related to thrombocytopenia.


CONCLUSIONS
Nuvaring, in our preliminary findings, may be considered to be an highly effective contraceptive method for female transplant recipients that additionally regulate menstrual bleeding and seems to positively influence well-being. Vaginal administration may diminish the chance of drug interactions and therefore be safer for patients.
Paternoster
D M
DM
Department of Obstetrics and Gynecology, University of Novara, Novara, Italy.
Riboni
F
F
Bertolino
M
M
Garofalo
G
G
Lazzarich
E
E
Surico
N
N
Stratta
P
P
D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D001219:Aspartate Aminotransferases / Q000097:blood; D001794:Blood Pressure; D003271:Contraceptive Agents, Female / Q000032:analysis; D003274:Contraceptive Devices, Female / Q000009:adverse effects / Q000706:statistics & numerical data*; D017135:Desogestrel / Q000032:analysis; D005260:Female; D005500:Follow-Up Studies; D006339:Heart Rate; D006801:Humans; D016030:Kidney Transplantation / Q000502:physiology*; D016031:Liver Transplantation / Q000502:physiology*; D008597:Menstrual Cycle; D011247:Pregnancy; D011256:Pregnancy Outcome; D012449:Safety
D003271:Contraceptive Agents, Female; C044815:etonogestrel; D017135:Desogestrel; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase