Evaluation of Efficacy, Safety and Tolerability of VeraCept IUD



Status:Recruiting
Healthy:No
Age Range:Any - 45
Updated:4/5/2019
Start Date:August 22, 2018
End Date:October 2024
Contact:Monique Gagnon
Email:monique.gagnon@synteract.com
Phone:760-268-8213

Use our guide to learn which trials are right for you!

A Phase 3, Prospective, Multi-Center, Single-Arm, Open-Label Study to Evaluate VeraCept™, a Long-Acting Reversible Intrauterine Contraceptive for Contraceptive Efficacy, Safety, and Tolerability

To assess the contraceptive efficacy (prevention of pregnancy) of VeraCept

Study Design:

Prospective, multi-center, single-arm, open-label, Phase 3 clinical study to 3 years with
extension up to 5 years

Number of Subjects:

Approximately 1,605 subjects will be enrolled into the study

Study Population:

Post-menarcheal, pre-menopausal women up to age 45 years, who are at risk for pregnancy and
who desire a long-term intrauterine contraceptive for birth control will be eligible for this
study.

Primary Endpoint:

The primary endpoint is the contraceptive efficacy through 3 years of use, as assessed by the
Pearl Index.

Secondary endpoints:

Contraceptive Efficacy:

- Pearl Index at Years 4 and 5, as well as cumulatively through Years 4 and 5.

- Pregnancy percentage by life table analysis (Kaplan-Meier) at Years 1, 2, 3, 4 and 5

Study drug placement:

- Ease of VeraCept placement

- Placement success

Safety:

- Serious adverse events (SAEs)

- Adverse events (AEs)

- Pelvic infection (pelvic inflammatory disease (PID) or endometritis)

- Ectopic pregnancies

- Uterine perforations

- Dysmenorrhea

- Abdominal pain

- Expulsion rates at Years 1, 2, 3, 4 and 5

Tolerability:

- Bleeding and spotting patterns

- Insertion pain assessed immediately after insertion

- Continuation rates at Years 1, 2, 3, 4 and 5

- Reasons for discontinuation Return to fertility

- Pregnancy rate in subjects who request VeraCept removal specifically to become pregnant.
Subjects who desire pregnancy after having VeraCept removed will be followed for either
1 year, until they decide to no longer try to conceive or they become pregnant,
whichever comes first.

Inclusion Criteria:

1. Post-menarcheal, pre-menopausal females up to 45 years of age at the time of informed
consent/assent and in good general health;

2. History of regular menstrual cycles defined as occurring every 21-35 days when not
using hormones or prior to recent pregnancy or spontaneous or induced abortion;

3. Sexually active with a male partner who has not had a vasectomy;

4. Reasonably expect to have coitus at least once monthly during the study period;

5. In a mutually monogamous relationship of at least 3 months duration;

6. Seeking to avoid pregnancy for the duration of the study;

7. Willing to use the study drug as the sole form of contraception;

8. Willing to accept a risk of pregnancy;

9. Subjects who are age 21 or older, at time of informed consent, must have a normal
papanicolaou test (Pap) or atypical squamous cells of undetermined significance
(ASC-US) with negative high risk human papilloma virus (HPV) test result within the
appropriate screen timeframe per American Society for Colposcopy and Cervical
Pathology (ASCCP) guidelines, and prior to the study IUD insertion. Alternatively, the
subject must have had a colposcopy performed within the appropriate screen timeframe,
and prior to the study IUD insertion that showed no evidence of dysplasia requiring
treatment per ASCCP guidelines, or treatment was performed and follow-up at least 6
months after the treatment showed no evidence of disease by clinical evaluation;

10. Able and willing to comply with all study tests, procedures, assessment tools
(including e-diary) and follow-up;

11. Able and willing to provide and document informed consent and Authorization for
Release of Protected Health Information (PHI). Unemancipated subjects under 18 years
old must provide assent and have written parental consent documented on the consent
form consistent with local legal requirements;

12. Plan to reside within a reasonable driving distance of a research site for the
duration of the study.

13. Subject agrees not to self-remove VeraCept

Exclusion Criteria:

1. Known or suspected pregnancy; or at risk for pregnancy from unprotected intercourse
earlier in current cycle;

2. Subject who anticipates separation from her partner for more than a 6-month period
during use of VeraCept;

3. A previously inserted intrauterine device (IUD) that has not been removed by the time
the study IUD is placed;

4. History of previous IUD complications, such as perforation, expulsion, or pregnancy
with IUD in place;

5. Pain with current IUD;

6. Injection of hormonal contraceptive (e.g., Depo-Provera) within the last 10 months (if
injection greater than 3 months ago, must have had 2 normal menstrual cycles since the
last injection);

7. Planned use of any non-contraceptive estrogen, progesterone or testosterone any time
during the 60 months of study participation;

8. Exclusively breastfeeding before return of menses; lactating women will be excluded
unless they have had 2 normal menstrual periods prior to enrollment;

9. Unexplained abnormal uterine bleeding (suspicious for a serious condition), including
bleeding 4 weeks post-septic abortion or puerperal sepsis;

10. Severely heavy or painful menstrual bleeding;

11. Suspected or known cervical, uterine or ovarian cancer, or unresolved clinically
significant abnormal Pap smear requiring evaluation or treatment;

12. Any history of gestational trophoblastic disease with or without detectable elevated
ß-human chorionic gonadotropin (ß-hCG) levels, or related malignant disease;

13. Any congenital or acquired uterine anomaly that may complicate study drug placement,
such as:

- Submucosal uterine leiomyoma

- Asherman's syndromes

- Pedunculated polyps

- Bicornuate uterus

- Didelphus or uterine septa

14. Any distortions of the uterine cavity (e.g. fibroids), that, in the opinion of the
investigator, are likely to cause issues during insertion, retention or removal of the
IUD;

15. Known anatomical abnormalities of the cervix such as severe cervical stenosis, prior
trachelectomy or extensive conization that, in the opinion of the investigator would
prevent cervical dilation and study drug placement;

16. Untreated acute cervicitis or vaginitis within the past 3 months;

17. Known or suspected human immunodeficiency virus (HIV) infection or clinical AIDS;

18. Subjects who have an established immunodeficiency;

19. Known intolerance or allergy to any components of VeraCept including intolerance or
allergy to nickel, titanium, or copper, and including Wilson's Disease;

20. Currently participating or planning future participation in a research study of an
investigational drug or device during the course of this investigational study.
Subject must have waited at least 30 days from exiting their last study prior to
informed consent in this study;

21. Subject has been enrolled in a previous VeraCept study;

22. Known or suspected alcohol or drug abuse within 12 months prior to the screening
visit;

23. Any general health, mental health or behavioral condition that, in the opinion of the
investigator, could represent an increased risk for the subject or would render the
subject less likely to provide the needed study information;

24. Study staff or a member of the immediate family of study staff.
We found this trial at
41
sites
Houston, Texas 77030
Phone: 713-795-5964
?
mi
from
Houston, TX
Click here to add this to my saved trials
1648 Pierce Dr NE
Atlanta, Georgia 30322
(404) 727-5640
Phone: 404-778-1358
Emory University School of Medicine Emory University School of Medicine has 2,359 full- and part-time...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
5920 Saratoga Blvd
Corpus Christi, Texas 78414
361-906-9178
?
mi
from
Corpus Christi, TX
Click here to add this to my saved trials
425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Phone: 317-948-6608
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Ann Arbor, Michigan 48109
Phone: 734-764-4048
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Berkeley, California 94710
Phone: 800-300-5767
?
mi
from
Berkeley, CA
Click here to add this to my saved trials
Carlsbad, California 92010
Phone: 269-372-7800
?
mi
from
Carlsbad, CA
Click here to add this to my saved trials
Charleston, South Carolina 29407
Phone: 843-766-5045
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Chattanooga, Tennessee 37404
Phone: 423-648-7794
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
Cincinnati, Ohio 45267
Phone: 513-584-4100
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Columbus, Ohio 43210
Phone: 614-293-0075
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Decatur, Georgia 30034
Phone: 404-534-9359
?
mi
from
Decatur, GA
Click here to add this to my saved trials
Denver, Colorado 80218
Principal Investigator: Arthur Waldbaum, MD
Phone: 303-293-3733
?
mi
from
Denver, CO
Click here to add this to my saved trials
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
?
mi
from
Durham, NC
Click here to add this to my saved trials
Fort Wayne, Indiana 46825
Phone: 260-432-4400
?
mi
from
Fort Wayne, IN
Click here to add this to my saved trials
1319 Punahou St
Honolulu, Hawaii 96826
(808) 983-6000
Phone: 808-375-3785
Kapiolani Medical Center for Women and Children Hawai‘i Pacific Health is an integrated health care...
?
mi
from
Honolulu, HI
Click here to add this to my saved trials
Idaho Falls, Idaho 83404
Phone: 208-497-0600
?
mi
from
Idaho Falls, ID
Click here to add this to my saved trials
Jackson, Tennessee 38301
Phone: 731-660-8379
?
mi
from
Jackson, TN
Click here to add this to my saved trials
2881 North Tenaya Way
Las Vegas, Nevada 89128
Phone: 702-242-8800
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
3600 Wilshire Boulevard
Los Angeles, California 90010
Phone: 800-398-1998
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Manchester, Missouri 63088
Phone: 314-531-7526
?
mi
from
Manchester, MO
Click here to add this to my saved trials
Marrero, Louisiana 70072
Phone: 504-934-8093
?
mi
from
Marrero, LA
Click here to add this to my saved trials
Minneapolis, Minnesota 55114
Principal Investigator: Christy Boraas, MD
Phone: 651-696-5514
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
New York, New York 10032
Phone: 212-305-6098
?
mi
from
New York, NY
Click here to add this to my saved trials
Norfolk, Virginia 23502
Phone: 757-471-3375
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
Norfolk, Virginia 23507
Phone: 757-446-0579
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19114
Principal Investigator: Eugene Andruczyk, MD
Phone: 215-676-6696
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19104
Phone: 215-615-0381
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15213
Phone: 412-641-5496
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Portland, Oregon 97239
Phone: 503-494-3666
?
mi
from
Portland, OR
Click here to add this to my saved trials
Sacramento, California 95817
Phone: 916-734-6846
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
Salt Lake City, Utah 84107
Phone: 801-288-0607
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
Salt Lake City, Utah 84132
Phone: 801-213-2774
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
San Diego, California 92108
Phone: 619-521-2830
?
mi
from
San Diego, CA
Click here to add this to my saved trials
Scottsdale, Arizona 85251
Phone: 480-305-7423
?
mi
from
Scottsdale, AZ
Click here to add this to my saved trials
3216 Northeast 45th Place
Seattle, Washington 98105
Phone: 206-522-3330
?
mi
from
Seattle, WA
Click here to add this to my saved trials
1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
Phone: 206-616-4939
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Stanford, California 94305
Phone: 650-721-1562
?
mi
from
Stanford, CA
Click here to add this to my saved trials
Tucson, Arizona 85712
Phone: 520-257-3881
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
Upland, California 91786
Phone: 909-981-5321
?
mi
from
Upland, CA
Click here to add this to my saved trials
West Palm Beach, Florida 33409
Phone: 561-478-3177
?
mi
from
West Palm Beach, FL
Click here to add this to my saved trials