Study of Efficacy, Cycle Control, and Safety of a NES-E2 Contraceptive Vaginal Ring

Conditions:Contraception, Contraception
Therapuetic Areas:Reproductive
Age Range:18 - 35
Start Date:February 12, 2018
End Date:June 20, 2020
Contact:Lesley Aycock

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A Multicenter, Open-label Randomized Study on the Efficacy, Cycle Control and Safety of a Contraceptive Vaginal Ring Delivering a Daily Dose of Nestorone® and Estradiol (NES-E2 CVR).

This will be a multi-site, open-label, randomized clinical trial. The investigators will
randomize 300 eligible participants in a 1:1 ratio to two different treatment regimens that
are to be followed when using a contraceptive vaginal ring delivering a daily dose of
Nestorone® and estradiol (NES-E2 CVR).

The total duration of the study for each participant is expected to be approximately
13.5-15.5 months: including screening and enrollment (up to 8 weeks), 12 months of
participation, and a post-removal follow up period removal of at least 17 days. After
enrollment, subject visits occur at day 31, 92, 183, 274, and 364 with telephone calls at day
60, 120, 150, 210, 240, 300, and 330. Subjects will use a home pregnancy test 17 days
post-removal of the ring and will call the site report the result and for safety follow-up.
Another phone call will be required after that if the subject chooses not to being a hormonal
contraceptive; this call will occur at the time of the subject's first spontaneous menses.

Subject recruitment is expected to begin Q1 (in the first quarter of) 2018 and is planned to
continue through Q1 2019. However, if the enrollment rate declines, the enrollment period may
be extended beyond this date. If this enrollment timeline is met, all subjects should finish
active treatment by approximately the end of Q1 2020. The end of the study will occur when
the last subject to be enrolled has completed her post-removal telephone call(s).

Preliminary results of the study are expected to be available Q3 of 2020 based on the current
study plan.

Inclusion Criteria:

1. Good general overall health with no chronic medical conditions that result in periodic
exacerbations requiring significant medical care.

2. Age 18-35 years, inclusive, at the enrollment visit. (Note: subjects must be at least
18 years of age to provide consent.)

3. Have a regular menstrual cycle 21-35 days in duration when not using hormonal

4. Have an intact uterus and at least one ovary.

5. Consistent use of effective contraception during the preceding cycle with no
unprotected intercourse since last use (NOTE: women who use oral, transdermal,
vaginal, or implantable hormonal contraceptives in the preceding cycle must have
discontinued hormone use at least 4 days prior to start of treatment and must not have
had unprotected intercourse since discontinuing the method. Copper IUD or
Levonorgestrel releasing IUD users must have discontinued IUD use at least 4 days
prior to start of treatment and have experienced a spontaneous menses following IUD

6. No use of injectable contraceptives (e.g. depomedroxyprogesterone acetate) during the
10 months prior to screening unless the subject has returned to normal menses (two
consecutive menses) since last injection.

7. Have a negative pregnancy test at the enrollment visit.

8. Have a diastolic blood pressure (BP) <90 mm Hg and systolic BP <140 mm Hg after 5
minutes rest in sitting position at the admission visit (below hypertension stage 2).
(Note: History of hypertension stage 2 or higher, even if controlled with treatment,
is exclusionary.)

9. Willing to abstain from use of non-water based (including silicone based) vaginal
lubricants during the study that could adversely affect the ring, causing it to

10. Understand and sign an IRB-approved informed consent form prior to screening
activities (including fasting blood draws).

11. BMI ≤ 35 kg/m2 and not having previously undergone bariatric surgery.

12. Planning to have at least one act of heterosexual intercourse without the use of
another contraceptive method each month during study participation until end of
treatment and at risk for pregnancy.

Exclusion Criteria:

1. Planning pregnancy during study participation through the end of treatment visit.

2. Within 30 days post-partum, currently breast-feeding, or has not had a spontaneous

3. Post-abortal and has not had a spontaneous menses.

4. Abnormal genital bleeding.

5. Participating in another clinical trial involving an investigational product within
the last 30 days (prior to screening) or planning to participate in another clinical
trial during this study.

6. Not living in the catchment area of the study site.

7. Known hypersensitivity to progestins or estrogens.

8. Contraindications to combined estrogen-progestin contraceptive use including:

1. Thrombophlebitis or thromboembolic disorders.

2. Personal history of deep vein thrombophlebitis or thromboembolic disorders.

3. History of venous thrombosis or embolism in a first-degree relative <55 years of
age suggesting a familial defect in the blood coagulation system.

4. History of thrombosis or embolism OR any other personal or family history which
in the opinion of the investigator suggests increased risk.

5. History of stroke.

6. Known history of any of the following genetic mutations: Factor V Leiden
mutation, prothrombin mutation, antithrombin deficiency, or other clinically
significant thrombophilia.

7. Known or suspected carcinoma of the breast.

8. Carcinoma of the endometrium or other known or suspected estrogen-dependent

9. History of cholestatic jaundice of pregnancy or jaundice with prior hormonal
contraceptive use.

10. History of hepatic adenomas or carcinomas.

11. Known or suspected pregnancy.

12. Smoking in women who are or will be 35 years during the course of the trial;
women <35 years who smoke 15 cigarettes or more per day must be evaluated by the
investigator for inclusion based on risk factors that would increase their risk
for cardiovascular disease (CVD) and thromboembolism, e.g. lipid levels, glucose
level, BP, BMI, family history of CVD at a young age. Individuals who use other
forms of tobacco should be evaluated similarly by the investigator for inclusion
based on the amount of tobacco use and their risk factors.

13. History of retinal vascular lesions, unexplained partial or complete loss of

14. History of headaches with focal neurological symptoms (e.g., migraines with

15. Impaired mobility (e.g. wheelchair bound, bed-ridden) that, in the opinion of the
investigator, places the woman at increased risk of thrombosis.

9. Unevaluated vaginal discharge or vaginal lesions. Subjects diagnosed at screening with
a chlamydia or gonococcal infection may be included in the trial following treatment
completion; partner treatment is also recommended. Subjects with yeast,
trichomoniasis, or bacterial vaginosis infection requiring treatment may be enrolled
after treatment completion. Investigators should determine if subjects are at an
elevated risk for reinfection, e.g. multiple sex partners, untreated partner, and
whether such subjects can be included. Women with a history of genital herpes can be
included if outbreaks are infrequent.

10. Have a known clinically significant Pap test abnormality, as managed by normal
standard of care guidelines, that would require repeat evaluation or treatment during
study participation based on the initial Pap findings.

11. Known benign or malignant liver tumors, renal disease or active liver disease.

12. Invasive cancer (past history of any carcinoma or sarcoma, except non-melanoma skin

13. Current or past medically diagnosed severe depression, which, in the opinion of the
investigator, could be exacerbated by use of a hormonal contraceptive.

14. Known or suspected current alcohol dependence, chronic marijuana use, or any illicit
drug use that may affect metabolism/transformation of study product and/or study
treatment compliance. A chronic marijuana user is defined as someone who uses
marijuana 4 or more times per week for study purposes.

15. Elevated fasting clinical chemistry values or complete blood count (CBC) values
designated clinically significant by the investigator or medically qualified

16. Uncontrolled thyroid disease.

17. Known impaired hypothalamic-pituitary-adrenal axis.

18. Known hypersensitivity to silicone rubber.

19. History of toxic shock syndrome.

20. Vaginal anatomic abnormality such as cystocele or rectocele that would preclude
correct use of a vaginal ring.

21. Planning major surgery during study participation.

22. Severe current constipation.

23. Use of liver enzyme inducers or inhibitors on a regular basis.

24. Known HIV infection.

25. Use of any medications, including antibiotics that can significantly interfere with
the metabolism of hormonal contraceptives.

26. Have an anticipated need for regular condom use, defined as use of at least one condom
per month after enrollment.

27. Have issues or concerns (in the judgment of the investigator) that may compromise the
safety of the subject or confound the reliability of compliance and information
acquired in this study.

28. Any site staff member with delegated study responsibilities or a family member of a
site staff member with delegated study responsibilities.
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