Evaluation of ContraMed VeraCept Intrauterine Copper Contraceptive for Long Acting Reversible Contraception

Phase 2

Completed

• Conditions: Contraception
• Interventions: Drug: VeraCept

• Registration Number: NCT02446821
• Lead Sponsor: Sebela Women's Health Inc.

Brief Summary

Prospective, multi-center, single-arm, open-label, Phase II clinical study to evaluate the effectiveness, device placement, safety, and tolerability of VeraCept to support commencing a Phase III Clinical Study

Detailed Description

Up to 250 subjects will be consented, screened and have VeraCept placed, with a goal to have 2240 evaluable cycles at 12 months. It is planned that 225 of the 250 subjects will be within the 18-35 year age range, with a total of 2015 evaluable cycles. The remaining 25 subjects will be within the 35-40 year age range.

Follow-up: Physical assessment (office visit) will occur at weeks 6, 13, 26 and 52 after placement, with monthly telephone contact. For those subjects who wish to continue study device use after 12 months, follow-up office visits will occur every 6 months. Additional visits will be conducted if necessary for safety issues.

Follow-up after early study device removal:

Subjects requesting VeraCept removal to become pregnant will be followed to pregnancy or until the subject changes their mind about trying to get pregnant. All subjects in whom VeraCept is removed prior to 12 months, for any reason, will be required to use an alternative contraceptive for the first two weeks following removal. Progestin-only pills will be provided by the sponsor as a contraceptive option during this time unless the subject has a category 4 condition precluding their use.

Study Population: Pre-menopausal women ages 18 - 40, at risk for pregnancy, who are interested in using an intrauterine contraceptive for birth control will be eligible for this study. Subjects must provide written informed consent and meet the study subject selection criteria without any exclusions as outlined in the Clinical Investigation Plan (CIP).

Primary Effectiveness Outcome: The primary outcome measure is effectiveness, evaluated as the absence of pregnancy by 12 months, failure will be calculated by the Pearl Index.

Safety and Other Outcome

Measures: Safety and other outcome measures include:

Study Device Placement:

* Ease of placement

* Placement success

Safety:

* Serious Adverse Events

* Adverse Events

Tolerability:

* Bleeding and spotting patterns

* Discontinuation rate and reasons for discontinuation

Study Timeline

• Study First Submitted: 2015-04-24
• Study First Submitted QC: 2015-05-15
• Study First Posted: 2015-05-18
• Study Start: 2015-06-01
• Primary Completion: 2017-05
• Study Completion: 2019-03-22
• Results First Submitted: 2025-07-01
• Status Verified: 2025-08
• Results First Submitted QC: 2025-08-05
• Last Update Submitted: 2025-08-05
• Results First Posted: 2025-08-22
• Last Update Posted: 2025-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 286

Inclusion Criteria

1. Between 18-40 years of age at the time of study initiation;

   1.1 Enrollment will be targeted for 225 subjects aged 18-35 (for safety and effectiveness analyses) and an additional 25 subjects aged 36-40 (for safety only) (note: all subjects will be included in the analysis for device placement and tolerability);

2. Pre-menopausal, as determined by regular menstrual cycle (28 ± 5 days) for the last 3 months;

   2.1 Based on patient history, when not on hormonal contraceptives;

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

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

5. Married or in a steady relationship (e.g., 3-6 months);

6. Seeking to avoid pregnancy for the next 12 months;

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

8. Willing to accept a risk of pregnancy;

9. Normal PAP or ASC-US with negative high risk HPV test result within the appropriate screen timeframe, unless considered at risk;

10. Able and willing to comply with all study tests, procedures, assessment tools and follow-up; and

11. Able and willing to provide and document informed consent and Authorization for Release of Protected Health Information (PHI).

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 1 cycle within the next 12 months;

3. A previously inserted IUD that has not been removed by the time VeraCept is placed;

4. History of previous IUD complications, such as perforation, expulsion, infection (pelvic inflammatory disease) or pregnancy with IUD in place;

5. Injection of hormonal contraceptive (e.g., Depo-Provera) within the last 10 months;

   5.1 Must have had 2 normal menstrual cycles since the last injection;

6. Planned use of any non-contraceptive estrogen, progesterone or testosterone any time during the 12 months of study participation;

7. Postpartum, prior to a minimum of 6 weeks or complete uterine involution;

8. Exclusively breastfeeding before return of menses; Lactating women will be excluded unless they have had two normal menstrual periods.

   8.1 Must have had 2 normal spontaneous menstrual cycles since delivery

9. Unexplained abnormal uterine bleeding (suspicious for serious condition), before evaluation; Immediately 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-hCG levels, or related malignant disease;

13. Known anatomical abnormalities of the uterine cavity that may complicate IUD placement, such as:

    13.1 Submucosal uterine leiomyoma

    13.2 Asherman's syndrome

    13.3 Pedunculated polyps

    13.4 Bicornuate uterus

    13.5 Didelphus or uterine septa

14. 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 device placement;

15. Current or recent (within the last 3 months) pelvic infection (cervix, endometrium, or fallopian tubes), or mucopurulent cervicitis;

16. High risk for STDs (e.g., multiple sexual partners);

17. Known or suspected AIDS;

18. Known intolerance or allergy to nickel or copper, including Wilson's Disease;

19. Currently participating or planning future participation in a research study of an investigational drug or device during the course of this investigational study;

20. Subject had VeraCept placed previously or had 2 attempts at placement;

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

22. Any general 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VeraCept IUD System	VeraCept	All women will receive VeraCept.

Primary Outcome Measures

Name	Time	Method
The Primary Outcome Measure is Effectiveness as Calculated by the Pearl Index	12 months	The Pearl Index is calculated as the number of on-treatment pregnancies per 100 woman-years of exposure. On-treatment pregnancy is defined as the estimated conception date being on or after the insertion date (must be a successful insertion) and no more than 7 days after the study drug is removed or expelled. One women year is defined as comprising thirteen 28-day cycles. A lower Pearl Index indicates greater contraceptive effectiveness.

Secondary Outcome Measures

Name	Time	Method
VeraCept Placement Success	Visit 1 (Day 1)/ VeraCept Placement	The number and percentage of subjects with either a successful or unsuccessful placement will be summarized
Ease of VeraCept Placement	Visit 1 (Day 1)/ VeraCept Placement	Ease of placement of the VeraCept was assessed by the clinician immediately following device placement. The clinician rated the ease of placement using the following options: "Very Easy," "Easy," "Neither Easy nor Hard," "Hard," or "Very Hard." This rating was based on the clinician's experience during the placement procedure.
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)	Cycle 1 to Cycle 13 (post IUD placement). Each cycle is 28 days.	Bleeding and spotting patterns will be summarized for the first year of treatment (Cycle 1 to Cycle 13) by the mean number of days in each 28-day cycle with bleeding or spotting, bleeding only, and spotting only

Trial Locations

Locations (11)

Essential Access Health (formerly California Family Health Council); 🇺🇸 Los Angeles, California, United States

University of California Davis Health System; 🇺🇸 Sacramento, California, United States

University of Colorado; 🇺🇸 Aurora, Colorado, United States

Healthcare Clinical Data, Inc; 🇺🇸 Miami, Florida, United States

Columbia University Medical Center; 🇺🇸 New York, New York, United States

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States

Oregon Health and Sciences University; 🇺🇸 Portland, Oregon, United States

Clinical Research of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Advanced Research Associates; 🇺🇸 Corpus Christi, Texas, United States

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