| Eligibility |
Inclusion Criteria
All of the following criteria must be met for the participants to be eligible for the
study:
1. Healthy women, sterile or at risk of becoming pregnant, inclusive of ages 18 to 35*
years at the enrollment visit.
2. Intact uterus and both ovaries.
3. Prior history of regular menstrual cycles that usually occur every 28 ± 7 days when
not using hormonal contraception; if postpartum or post-abortal, history of regular
menstrual cycles of 21 to 35 days in length and resumption of at least one cycle with
a cycle length consistent with her past cycles.
4. In the opinion of the Investigator, able to comply with the protocol, eg, live within
the study site catchment area or within a reasonable distance from the study site.
5. Willing to use oral contraception for one month prior to the initial insertion of
Annovera.
6. Willing to abstain from tampon use except during the prescribed time of the trial.
7. Willing to abstain from sexual intercourse during tampon use.
8. Signed informed consent prior to entry into the trial.
- Upper age limit based on normal ovarian changes (ovarian reserve) prevalent in
women with advancing age (> 35 years of age) that may alter patterns of follicle
development and/or confound interpretations of data regarding patterns of
follicle development
Exclusion Criteria
Contraindications for enrollment will be the same as those for use of CHCs and additional
criteria important to the objectives of this study and include:
1. Known hypersensitivity to estrogens or progestins.
2. Pregnant, trying to become pregnant, or breastfeeding.
3. Known hypersensitivity to silicone rubber.
4. Undiagnosed abnormal vaginal bleeding.
5. Undiagnosed vaginal discharge, vaginal lesions or abnormalities. Participants
diagnosed at screening with a chlamydia or gonococcus infection may be included in the
trial following treatment; partner treatment is also recommended. Investigators should
make a determination if participants are at high risk for reinfection, eg, multiple
sex partners, untreated partner, and whether such participants can be included.
6. History of pelvic inflammatory disease since the participant's last pregnancy.
7. History of toxic shock syndrome.
8. In accordance with the Bethesda system of classification: Women with a current (within
the last 20 months) abnormal Papanicolaou smear (Pap smear) suggestive of high-grade
pre-cancerous lesion (s), including high grade squamous intraepithelial lesion.
9. Cystoceles or rectoceles or other anatomical abnormality that would preclude use of a
vaginal ring.
10. Women planning to undergo major surgery during the trial.
11. Women who smoke 15 cigarettes or more per day must be evaluated by the Principal
Investigator (PI) for inclusion based on risk factors that would increase their risk
for cardiovascular disease and thromboembolism, eg, lipid levels, glucose level, blood
pressure (BP), body mass index (BMI), family history of cardiovascular disease at a
young age.
12. Current or past thrombophlebitis or thromboembolic disorders.
13. History of venous thrombosis or embolism in a first-degree relative, < 55 years of age
suggesting a familial defect in the blood coagulation system, which in the opinion of
the PI, suggests that use of a hormonal contraceptive could pose a significant risk.
14. Cerebrovascular or cardiovascular disease.
15. History of retinal vascular lesions, unexplained partial or complete loss of vision.
16. Known or suspected carcinoma of the breast.
17. Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia.
18. Past history of any other carcinoma unless in remission for more than five years.
19. Current or history of medically diagnosed severe depression, which, in the opinion of
the Investigator, could be exacerbated by the use of a hormonal contraceptive.
20. Has a Type D personality type as assessed by the DS14 test (Standard Assessment of
Negative Affectivity, Social Inhibition and Type D Personality).
21. Headaches with focal neurological symptoms.
22. Severe constipation in the opinion of the Investigator.
23. History of cholestatic jaundice of pregnancy or jaundice with prior steroid use.
24. Benign or malignant liver tumors; active liver disease.
25. Diastolic BP > 85 mm Hg and/or systolic BP > 135 mm Hg after 5 to 10 minutes rest (at
Screening).
26. Known or suspected alcoholism or drug abuse within their lifetime. aa. Elevated serum
fasting clinical chemistry values or complete blood count (CBC) values designated
clinically significant by the Investigator and/or medically qualified
Sub-Investigator.
bb. Screening hemoglobin levels less than 12.5 g/dL or hematocrit less than 38%.
cc. Participation in another clinical trial involving an investigational drug within the
last 30 days (prior to Screening). dd. BMI > 29 kg/m2. ee. Use of liver enzyme inducers on
a regular basis. ff. Use of monthly injectable contraceptives, unless suspended 2 months
before initiation of the treatment. Use of Depo-Provera® [depot medroxyprogesterone
acetate] unless suspended 9 months before treatment.
gg. Current use of implanted hormonal contraceptives, including Mirena® [progestin
containing intrauterine system], Jadelle®, Norplant®, Implanon® or Nexplanon (if now
available in the USA).** hh. Known HIV, Hepatitis B or Hepatitis C infection. ii. History
of frequent vaginal infections in the opinion of the PI. jj. Use of any oral medications or
supplements during the trial that could interfere with the metabolism of the contraceptive
hormones. Use of any vaginal preparations during Treatment Cycle 1 or Treatment Cycle 2.
Use of any medication during the study must be reviewed and approved by the Medical Monitor
*Women using non-hormonal intrauterine devices are permitted to enroll in the study.
**Participants using any of the implanted hormonal methods who request removal for reasons
unrelated to the purpose of enrollment in this study may be considered for participation.
|
