Evaluation of Efficacy, Safety and Tolerability of VeraCept IUD

Women at Risk for Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03633799
• Other study ID #: CMDOC-0042
• Status: Active, not recruiting
• Phase: Phase 3
• 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
• 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.

Related Conditions & MeSH terms

• Women at Risk for Pregnancy

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.