CompletedPhase 2

Evaluation of the Efficacy and Safety of LevoCept

United States279 participantsStarted 2016-11

Plain-language summary

To evaluate the effectiveness, device placement, safety, and tolerability of LevoCept to support commencing a Phase III Clinical Study

Age range18 Years – 40 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Between 18-40 years of age at the time of study initiation;
✓.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);
✓. Pre-menopausal, as determined by regular menstrual cycle (28 ± 7 days) for the last 3 months;
✓.1 Based on patient history, when not on hormonal contraceptives;
✓. Sexually active with a male partner who has not had a vasectomy;
✓. Reasonably expected to have to coitus at least once monthly during the study period.
✓. In a mutually monogamous relationship of at least 3-6 months duration;
✓. Seeking to avoid pregnancy for the next 12 months;

✕. Known or suspected pregnancy; or at risk for pregnancy from unprotected intercourse earlier in current cycle
✕. Subject who anticipates separation from her partner for more than 1 cycle within the next 12 months;
✕. A previously inserted IUD that has not been removed by the time LevoCept is placed;
✕. History of previous IUD complications, such as perforation, expulsion, infection (pelvic inflammatory disease) or pregnancy with IUD in place.;
✕. Injection of hormonal contraceptive (e.g., Depo-Provera) within the last 10 months;
✕.1 Must have had 2 normal menstrual cycles since the last injection;
✕. Planned use of any non-contraceptive estrogen, progesterone or testosterone any time during the 12 months of study participation;
✕. Postpartum, prior to a minimum of 6 weeks and complete uterine involution;

Contraceptive Efficacy Through During LevoCept Use

Timeframe: 1 Year, 2 Years, and 3 Years

Cumulative Pregnancy Percentage

Timeframe: Years 1-3

NCT IDNCT02882191

SponsorSebela Women's Health Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-07-17

Results submitted2026-03-13

Who can participate

Age range18 Years – 40 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Between 18-40 years of age at the time of study initiation;
✓.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);
✓. Pre-menopausal, as determined by regular menstrual cycle (28 ± 7 days) for the last 3 months;
✓.1 Based on patient history, when not on hormonal contraceptives;
✓. Sexually active with a male partner who has not had a vasectomy;
✓. Reasonably expected to have to coitus at least once monthly during the study period.
✓. In a mutually monogamous relationship of at least 3-6 months duration;
✓. Seeking to avoid pregnancy for the next 12 months;

✕. Known or suspected pregnancy; or at risk for pregnancy from unprotected intercourse earlier in current cycle
✕. Subject who anticipates separation from her partner for more than 1 cycle within the next 12 months;
✕. A previously inserted IUD that has not been removed by the time LevoCept is placed;
✕. History of previous IUD complications, such as perforation, expulsion, infection (pelvic inflammatory disease) or pregnancy with IUD in place.;
✕. Injection of hormonal contraceptive (e.g., Depo-Provera) within the last 10 months;
✕.1 Must have had 2 normal menstrual cycles since the last injection;
✕. Planned use of any non-contraceptive estrogen, progesterone or testosterone any time during the 12 months of study participation;
✕. Postpartum, prior to a minimum of 6 weeks and complete uterine involution;