A multicenter, open-label study on the efficacy, cycle control and safety of a contraceptivevaginal ring delivering a daily dose of 150 µg of Nestorone(R) and 15 µg of ethinyl estradiol (150/15 NES/EE CVR)

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: 2200

Inclusion Criteria

a. Healthy women, aged 18-<40 years who wish to use a combined hormonal contraceptive.
b. Women not intending to become pregnant for 13 months.
c. Intact uterus and both ovaries.
d. Prior history of regular menstrual cycles of 28 ± 7 days when not using hormonal contraception; if postpartum or postabortal, history of regular menstrual cycles of 21-35 days in length and at least one cycle (2 menses) with a cycle length consistent with her past cycles.
e. Sexually active (currently) and willing to discontinue current contraceptive method to participate in the study.
f. In the opinion of the investigator, able to comply with the protocol, e.g. live within the clinic catchment area or within a reasonable distance from the clinic.
g. Do not meet any of the exclusion criteria.
h. Signed informed consent prior to entry into the trial.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

a. Known hypersensitivity to estrogens or progestins.
b. Known hypersensitivity to silicone rubber.
c. Known or suspected pregnancy.
d. History of infertility of >1.0 year in woman or her male partner.
e. History of vasectomy or sterility in male partner.
f. Undiagnosed abnormal genital bleeding.
g. Undiagnosed vaginal discharge or vaginal lesions or abnormalities. (Subjects diagnosed at screening with a chlamydia or gonococcus infection may be included in the trial following treatment; partner treatment is also recommended. Subjects at high risk for reinfection can be included or excluded per investigator’s discretion.)
h. History of pelvic inflammatory disease since last pregnancy episode.
i. History of toxic shock syndrome.
j. Current abnormal Pap smear (women who have abnormal Pap smears but are ASCUS HPV negative may participate provided there is follow-up for this finding per standard of care).
k. Cystoceles or rectoceles or other anatomical abnormality that would preclude use of a vaginal ring.
l. Women planning to undergo major surgery.
m. Smoking more than 15 cigarettes per day if < 35yrs; any amount of smoking if 35 years and over.
n. Breastfeeding.
o. Current or past thrombophlebitis or thromboembolic disorders.
p. History of venous thrombosis or embolism in a first-degree relative, <55 years of age suggesting familial defect in blood coagulation system
q. Cerebrovascular or cardiovascular disease.
r. History of retinal vascular lesions, unexplained partial or complete loss of vision.
s. Known or suspected carcinoma of the breast.
t. Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia.
u. Past history of any other carcinoma unless in remission for more than 5 years.
v. Current or history of medically diagnosed severe depression, which, in the opinion of the investigator, could be exacerbated by use of a hormonal contraceptive.
w. Headaches with focal neurological symptoms.
x. Severe constipation.
y. History of cholestatic jaundice of pregnancy or jaundice with prior steroid use.
z. Benign or malignant liver tumors; active liver disease.
aa. Diastolic blood pressure (BP) >= 85 mm Hg and/or systolic BP >=135 mm Hg after 5-10 min. rest.
bb. Known or suspected alcoholism or drug abuse.
cc. Abnormal serum chemistry values according to the physician’s judgment.
dd. Participation in another clinical trial within last 30 days.
ee. Weight >95 kg or >209 lbs.
ff. Use of liver enzyme inducers on a regular basis.
gg. Use of monthly injectable contraceptives (e.g. cyclofem) unless suspended 2 months before initiation of treatment. Use of Depo-Provera(R) [depo-medroxyprogesterone (DMPA)] unless suspended 6 months before treatment.
hh. Current use of implanted hormonal contraceptives, including Mirena(R) [progestin containing intrauterine system (IUS)], Jadelle(R), Norplant(R) or Implanon(R). Subjects using these hormonal products who request removal for reasons unrelated to the purpose of enrollment in this study may be considered for participation.
ii. Current use of a non-hormonal IUD. Subjects with IUDs who request removal for reasons unrelated to the purpose of enrollment in this study may be considered for participation.
jj. Known HIV infection.
kk. Women at high risk of contracting HIV, e.g. women with multiple sex partners who need to use condoms consistently, injection drug users. If women enrolled in the study do use condoms to protect against STIs, they should be instructed that th

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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