nuvaring and etonogestrel

To identify at least one contraceptive vaginal ring that effectively inhibits ovulation and demonstrates cycle control that is non-inferior to NuvaRing

Topics: Adult; Contraceptive Agents, Female; Contraceptive Devices, Female; Desogestrel; Dose-Response Relationship, Drug; Drug Combinations; Drug Monitoring; Estradiol; Estrogens, Conjugated (USP); Ethinyl Estradiol; Female; Humans; Menstrual Cycle; Outcome Assessment, Health Care; Ovulation Inhibition

The aim of the study was to assess the efficacy and tolerability of the monthly vaginal ring (NuvaRing; 15 μg ethinylestradiol [EE] and 120 μg etonogestrel per day) compared with a monophasic (21/7) combined oral contraceptive (COC) containing 30 μg EE and 3 mg drospirenone in healthy Chinese women aged 18-40 years.. This was a phase III, open-label, randomised multicentre trial conducted in China. Participants received NuvaRing or COC for 13 cycles (3 weeks of ring/pill treatment followed by a 1-week ring-free/pill-free period). Contraceptive efficacy was assessed by in-treatment pregnancies and expressed by the Pearl Index (PI; number of pregnancies/100 woman-years of use). Cycle control was assessed by unscheduled (breakthrough) and absence of scheduled (withdrawal) bleeding events. Safety and tolerability were assessed throughout the study.. Participants were randomised either to the NuvaRing (n = 732) or to the COC (n = 214); 588 (82.4%) and 182 (78.4%) participants, respectively, completed the study. There were 10 in-treatment pregnancies in the NuvaRing group (PI 1.92; 95% confidence interval [CI] 0.92, 3.53) and five in the COC group (PI 3.12; 95% CI 1.01, 7.29). Breakthrough bleeding/spotting ranged from 18.6% (Cycle 1) to 4.2% (Cycle 11) for NuvaRing and from 21.6% (Cycle 1) to 7.9% (Cycle 11) for COC. Absence of withdrawal bleeding ranged from 8.6% (Cycle 1) to 3.0% (Cycle 11) for NuvaRing and from 14.6% (Cycle 1) to 6.4% (Cycle 5) for COC. For NuvaRing and COC, respectively, 26.6% and 25.0% of participants had treatment-related adverse events, and 7.0% and 9.1% discontinued the study as a result.. Once-monthly NuvaRing is efficacious and safe for use in Chinese women.

Topics: Adolescent; Adult; China; Contraceptives, Oral, Combined; Desogestrel; Drug Combinations; Dysmenorrhea; Ethinyl Estradiol; Female; Humans; Medication Adherence; Metrorrhagia; Young Adult

The objective of this study was to compare cycle control, cycle-related characteristics and bodyweight effects of NuvaRing with those of a combined oral contraceptive (COC) containing 30 microg of ethinyl estradiol and 3 mg of drospirenone.. A randomized, multicentre, open-label trial in which 983 women were treated (intent-to-treat population) with NuvaRing or the COC for 13 cycles.. Breakthrough bleeding or spotting during cycles 2-13 was in general less frequent with NuvaRing than that with the COC (4.7-10.4%) and showed a statistically significant odds ratio of 0.61 (95% confidence interval: 0.46, 0.80) with longitudinal analysis. Intended bleeding was significantly better for all cycles with NuvaRing (55.2-68.5%) than that with the COC (35.6-56.6%) (P < 0.01). Changes from baseline in mean bodyweight and body composition parameters were relatively small for both groups with no notable between-group differences.. NuvaRing was associated with better cycle control than the COC, and there was no clinically relevant difference between the two groups in bodyweight.

Topics: Administration, Oral; Adult; Androstenes; Body Composition; Body Weight; Contraceptive Devices, Female; Contraceptives, Oral; Desogestrel; Drug Combinations; Ethinyl Estradiol; Humans; Intrauterine Devices; Menstrual Cycle; Patient Compliance

This study sought to measure residual contraceptive hormone levels in vaginal rings as an adherence marker for monitoring product use in clinical trials.. Residual etonogestrel and ethinyl estradiol levels from used NuvaRings® of 26 self-reported adherent women enrolled in a clinical trial of vaginal ring acceptability were compared to those from 16 women who used NuvaRing® as their contraceptive choice.. Twenty-one (81%) clinical trial rings had contraceptive hormone levels within the range of those used as a contraceptive choice. Five returned rings had unused or discordant levels of residual contraceptive hormones.. Residual vaginal ring drug levels could help assess adherence in clinical trials.

Topics: Administration, Intravaginal; Clinical Trials as Topic; Contraceptive Agents, Female; Contraceptive Devices, Female; Desogestrel; Drug Combinations; Ethinyl Estradiol; Female; Humans; Kenya; Patient Compliance; United States

Young women under the age of 16 years require special consideration when requesting contraception. Such young women can give voluntary consent, which enables prescription and supply providing that the practitioner has determined that the minor is sufficiently mature to understand the details of the method and its use. All reversible methods may be appropriate but it is necessary to provide information in a form that is fully understood. For women with pre-existing medical conditions including obesity, the benefits and risks of the use of individual methods needs to be weighed against the risks of pregnancy for that woman.

Topics: Adolescent; Adult; Anemia; Breast Diseases; Cardiovascular Diseases; Condoms; Contraception; Contraceptive Agents, Female; Contraindications; Desogestrel; Diabetes Mellitus; Drug Combinations; Drug Implants; Epilepsy; Ethinyl Estradiol; Female; Heart Valve Diseases; Humans; Hypertension; Inflammatory Bowel Diseases; Injections; Intrauterine Devices; Levonorgestrel; Liver Diseases; Lupus Erythematosus, Systemic; Medroxyprogesterone Acetate; Migraine Disorders; Norethindrone; Norgestrel; Obesity; Patient Preference; Pregnancy; Progestins; Stroke; Young Adult