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Evaluation of the Efficacy, Safety, and Tolerability of LevoCept

Sponsor
Sebela Women's Health Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT04457076
Collaborator
PRA Health Sciences (Industry)
1,525
Enrollment
30
Locations
1
Arm
72
Anticipated Duration (Months)
50.8
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

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 1,525 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1525 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
LevoCept Intrauterine Device (IUD)LevoCept Intrauterine Device (IUD)
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 3, Prospective, Multi-Center, Single-Arm, Open-Label Study to Evaluate LevoCept™, a Long-Acting Reversible Intrauterine System for Contraceptive Efficacy, Safety, and Tolerability
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Jul 1, 2026
Anticipated Study Completion Date :
Jul 1, 2028

Arms and Interventions

Arm Intervention/Treatment
Experimental: LevoCept

LevoCept™ Intrauterine Contraceptive

Drug: LevoCept
Levonorgestrel-Releasing Intrauterine System

Outcome Measures

Primary Outcome Measures

  1. Contraceptive efficacy through 3 years of use as calculated by the Pearl Index [through 3 years of use]

Secondary Outcome Measures

  1. Contraceptive efficacy at Years 4 and 5 as calculated by the Pearl Index [Years 4 and 5 and cumulatively through Years 4 and 5]

  2. Pregnancy percentage [Years 1 through 5]

  3. Ease of LevoCept placement [Day 1 / LevoCept placement]

    Ease of LevoCept placement will be summarized for the Safety population as reported by the investigator (Very easy, Easy, Neither Easy nor Hard, Hard, Very Hard).

  4. LevoCept Placement success [Day 1 / LevoCept placement]

    The number of subjects with either a successful or unsuccessful placement will be summarized

  5. Incidence of AEs and SAEs [5 years]

  6. Bleeding and spotting patterns [Through year 1]

  7. Insertion pain assessed immediately after insertion [Day 1, 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

  8. Cumulative LevoCept continuation rates [Years 1 through 5]

    Continuation rates at Years 1, 2, 3, 4 and 5, Reasons for discontinuation will be summarized.

  9. Cumulative LevoCept expulsion rates [Years 1 through 5]

  10. Return to Fertility. Only for subjects requesting LevoCept removal to become pregnant. [Subjects will be followed for either 1 year, until they decide to no longer try to conceive or they become pregnant, whichever comes first.]

  11. Release rate of LNG from the IUS and resulting pharmacokinetics of LNG (PK substudy) [Years 1 through 5]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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 nor other known fertility problems;

  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 at time of consent;

  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 must be in compliance with cervical cancer screening guidelines per the American Society for Colposcopy and Cervical Pathology (ASCCP) guidelines without evidence of disease. Subjects who are age 21 to 24 y/o, at time of informed consent, must have a normal Papanicolaou test (Pap), atypical squamous cells of undetermined significance (ASC-US), or low-grade squamous intraepithelial lesion (LSIL). Subjects who are 25 or older at the time of informed consent must have a normal Pap test or an ASC-US result with a negative high-risk human papilloma virus (HPV) test result within the appropriate screen timeframe per 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/legal guardian consent documented on the consent form consistent with local legal requirements;

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

  13. Subject agrees not to intentionally self-remove LevoCept

Exclusion Criteria:

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

  2. Has had any procedure for or causing sterility (e.g. tubal ligation procedure);

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

  4. A previously inserted IUD/IUS that has not been removed by the time the study IUS is placed;

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

  6. Pain with current IUD/IUS;

  7. 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;

  8. Subject is <4 weeks post-pregnancy (postpartum, spontaneous or induced abortion)

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

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

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

  12. Severely heavy or painful menstrual bleeding;

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

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

  15. 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

  1. 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 IUS;

  2. 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;

  3. Untreated or unresolved acute cervicitis or vaginitis;

  4. Known or suspected breast cancer or other progestin-sensitive cancer now or in the past;

  5. Known acute liver disease or liver tumor;

  6. Subjects who have an established immunodeficiency;

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

  8. At high risk for sexually transmitted infections (e.g. multiple sexual partners);

  9. Known intolerance or allergy to any components of LevoCept, including intolerance or allergy to levonorgestrel, nickel, titanium, or silicone;

  10. 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;

  11. Subject has previously been enrolled in a VeraCept or LevoCept study (including the current study);

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

  13. 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;

  14. Study staff or a member of the immediate family of study staff.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Essential Access Health-Berkeley Berkeley California United States 94710
2 Essential Access Health-Los Angeles Los Angeles California United States 90010
3 University of California Davis Health System Department of Obstetrics and Gynecology Sacramento California United States 95817
4 WR-Medical Center for Clinical Research San Diego California United States 92108
5 Women's Health Care Research San Diego California United States 92111
6 Stanford University, Medical Center, Obstetrics and Gynecolocy Stanford California United States 94305
7 University Of Colorado Department of Obstetrics & Gyncology Aurora Colorado United States 80045
8 Downtown Women's Health Care Denver Colorado United States 80209
9 Emory University School of Medicine Gynecology/Obstetrics Atlanta Georgia United States 30308
10 Soapstone Center for Clinical Research Decatur Georgia United States 30034
11 University of Hawaii Honolulu Hawaii United States 96826
12 Women's Health Advantage Fort Wayne Indiana United States 46825
13 IU Health University Hospital Indianapolis Indiana United States 46202
14 Planned Parenthood North Central States Minneapolis Minnesota United States 55408
15 Planned Parenthood of the St. Louis Region and Southwest Missouri Manchester Missouri United States 63088
16 Rex Garn Mabey Jr., MD Las Vegas Nevada United States 89128
17 Columbia University Medical Center New York New York United States 10032
18 University of Cincinnati/Reproductive Medicine Research Cincinnati Ohio United States 45267
19 Ohio State University Columbus Ohio United States 43209
20 The Ohio State University Ob/Gyn Research Office Columbus Ohio United States 43210
21 Oregon Health & Science University Portland Oregon United States 97239
22 Hospital of the University of Pennsylvania Philadelphia Pennsylvania United States 19104
23 Clinical Research of Philadelphia, LLC Philadelphia Pennsylvania United States 19114
24 Magee-Womens Hospital, Center for Family Planning Research Pittsburgh Pennsylvania United States 15213
25 Advances In Health Houston Texas United States 77030
26 University of Utah Healthcare Health Sciences Center Salt Lake City Utah United States 84132
27 Tidewater Physicians for Women Norfolk Virginia United States 23502
28 Eastern Virginia Medical Norfolk Virginia United States 23507
29 Seattle Women's: Health, Research, Gynecology Seattle Washington United States 98105
30 University of Washington Medical Center Seattle Washington United States 98117

Sponsors and Collaborators

  • Sebela Women's Health Inc.
  • PRA Health Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sebela Women's Health Inc.
ClinicalTrials.gov Identifier:
NCT04457076
Other Study ID Numbers:
  • CMDOC-0062
First Posted:
Jul 7, 2020
Last Update Posted:
Apr 12, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sebela Women's Health Inc.
Contraception
IUD

Study Results

No Results Posted as of Apr 12, 2022