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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03633799
Other study ID # CMDOC-0042
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date August 22, 2018
Est. completion date September 22, 2027

Study information

Verified date August 2023
Source Sebela Pharmaceuticals Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

Study Design: Prospective, multi-center, single-arm, open-label, Phase 3 clinical study to 3 years with extension up to 8 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, 5, 6, 7 and 8 as well as cumulatively through Years 4, 5, 6, 7 and 8. - Pregnancy percentage by life table analysis (Kaplan-Meier) at Years 1, 2, 3, 4, 5, 6, 7 and 8 - The cumulative Pearl Index for Years 6 to 8 will be calculated as well as the cumulative pregnancy percentage for Years 6 to 8 using a life table analysis (Kaplan-Meier) only for the EP population. 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, 5, 6, 7 and 8 Tolerability: - Bleeding and spotting patterns - Insertion pain assessed immediately after insertion - Continuation rates at Years 1, 2, 3, 4, 5, 6, 7 and 8 - 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1620
Est. completion date September 22, 2027
Est. primary completion date September 22, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A to 45 Years
Eligibility 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 and has not had 2 normal menstrual cycles since the last injection; 7. Planned use of any non-contraceptive estrogen, progesterone or testosterone any time during 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
VeraCept
VeraCept Intrauterine Contraceptive is a hormone free, low dose, copper-releasing birth control method

Locations

Country Name City State
United States University of Michigan Von Voigtlander Women's Hospital Ann Arbor Michigan
United States Emory University School of Medicine Atlanta Georgia
United States Essential Access Health Berkeley California
United States Medical Research South, LLC Charleston South Carolina
United States Chattanooga Medical Research Chattanooga Tennessee
United States University of Cincinnati/Reproductive Medicine Research Cincinnati Ohio
United States The Ohio State University Ob/Gyn Research Office Columbus Ohio
United States Advanced Research Associates Corpus Christi Texas
United States Soapstone Center for Clinical Research Decatur Georgia
United States Downtown Women's Health Care Denver Colorado
United States Duke University Medical Center Durham North Carolina
United States Women's Health Advantage Fort Wayne Indiana
United States Advances In Health Houston Texas
United States Clinical Research Prime Idaho Falls Idaho
United States Indiana University Indianapolis Indiana
United States The Jackson Clinic, PA Jackson Tennessee
United States Altus Research, Inc Lake Worth Florida
United States Rex Garn Mabey Jr., MD Las Vegas Nevada
United States Lawrence OB/Gyn Clinical Research Lawrenceville New Jersey
United States Essential Access Health Los Angeles California
United States Planned Parenthood of the St. Louis Region and Southwest Missouri Manchester Missouri
United States Praetorian Pharmaceutical Research Marrero Louisiana
United States University of Minnesota/Planned Parenthood Minneapolis Minnesota
United States Columbia University Medical Center, Division of Family Planning New York New York
United States Eastern Virginia Medical Norfolk Virginia
United States Tidewater Physicians for Women Norfolk Virginia
United States Clinical Research of Philadelphia Philadelphia Pennsylvania
United States University of Pennsylvania/Penn Family Planning and Pregnancy Loss Center Philadelphia Pennsylvania
United States Magee-Womens Hospital, Center for Family Planning Research Pittsburgh Pennsylvania
United States OHSU Women's Health Research Unit Portland Oregon
United States University of California, Davis Health System Sacramento California
United States University of Utah Healthcare Health Sciences Center Salt Lake City Utah
United States Wasatch Clinical Research Salt Lake City Utah
United States Medical Center for Clinical Research San Diego California
United States Women's Health Care Research San Diego California
United States MomDoc Women's Health Research Scottsdale Arizona
United States Seattle Women's Health Seattle Washington
United States University of Washington Medical Center Seattle Washington
United States Stanford University, Medical Center, Obstetrics and Gynecolocy Stanford California
United States Copperstate OB/GYN Associates Tucson Arizona
United States Empire Clinical Research Upland California

Sponsors (2)

Lead Sponsor Collaborator
Sebela Women's Health Inc. Synteract, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary contraceptive efficacy through 3 years of use contraceptive efficacy through 3 years of use, as assessed by the Pearl Index through 3 years of use
Secondary Contraceptive efficacy at Years 4, 5, 6, 7 and 8 Pearl Index will be calculated for Years 4, 5, 6, 7, and 8 as well as cumulatively through Years 4, 5, 6, 7, and 8 Years 4, 5, 6, 7, and 8 and cumulatively through Years 4, 5, 6, 7, and 8
Secondary cumulative pregnancy percentage A life table analysis (using Kaplan-Meier) of pregnancies will be performed for the EP population to present the cumulative pregnancy percentage for Years 1 through 8 Years 1 through 8
Secondary Ease of VeraCept placement Ease of VeraCept placement will be summarized for the Safety population as reported by the investigator (Very easy, Easy, Neither Easy nor Hard, Hard, Very Hard). Visit 1 (Day 1) / VeraCept placement
Secondary VeraCept Placement success The number and percentage of subjects with either a successful or unsuccessful placement will be summarized for the ITT and Safety populations. Visit 1 (Day 1) / VeraCept placement
Secondary Incidence of AEs and SAEs Incidence of AEs and SAEs will be summarized for the ITT population, as well as for the Safety population for all subjects and the 36 to 45-year-old safety sub-population. 8 years
Secondary Bleeding and spotting patterns Bleeding and spotting patterns will be summarized for the ECYC population for the first year of treatment by the number of days in each 28-day cycle with bleeding or spotting, bleeding only and spotting only Through year 1
Secondary Insertion pain assessed immediately after insertion Summarized for subjects with and without prior prophylactic pain medication as measured by an 11-Point Numeric Pain Rating Scale. The scale being 0 - 10 with 0 being no pain and 10 being the worse pain Visit 1 (Day 1), immediately after insertion
Secondary Cumulative VeraCept continuation rates Cumulative VeraCept continuation rates for Years 1 through 8 will be summarized using Kaplan-Meier methods for the Safety population. The number and percentage of subjects with each reason for discontinuation will be summarized.
Continuation rates at Years 1, 2, 3, 4, 5, 6, 7 and 8 Reasons for discontinuation will be summarized.
Years 1 through 8
Secondary Cumulative VeraCept expulsion rates Cumulative VeraCept expulsion rates for Years 1 through 8 will be summarized using Kaplan-Meier methods for the Safety population. Years 1 through 8
Secondary Return to Fertility. Only for subjects requesting VeraCept removal to become pregnant. The number and percentage of subjects with each return to fertility response will be summarized for the Safety population. Subjects will be followed for either 1 year, until they decide to no longer try to conceive or they become pregnant, whichever comes first.
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04457076 - Evaluation of the Efficacy, Safety, and Tolerability of LevoCept Phase 3
Active, not recruiting NCT03785366 - A PK Study Comparing VeraCept vs. ParaGard Intrauterine Devices (IUDs) Phase 3