A Study to Evaluate the Efficacy and Safety of Subcutaneous Levonorgestrel Butanoate for Female Contraception

NCT07222228 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: CCN021B
• Study Type: interventional
• Target: 165
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a multicenter, open-label, Phase 2b study to evaluate the efficacy and safety of 2 LB SQ injections administered at a 4-month (approximately 17 weeks) interval for female contraception.

Conditions

Healthy Women; Female Contraception

Keywords

Female contraception

Outcome Measures

Primary Outcomes (1)

• To evaluate the contraceptive efficacy of 2 LB SQ injections administered at a 4-month (approximately 17 weeks)interval over 8 cycles

  As measured by The cumulative pregnancy percentage (calculated using Kaplan-Meier) through 8 cycles

  224 days

Secondary Outcomes (5)

• To assess the safety of 2 LB SQ injections

  240 days

• To further explore the contraceptive efficacy of 2 LB SQ injections

  224 days

• To explore bleeding patterns in participants receiving 2 LB SQ injections

  240 days

• To evaluate acceptability of 2 LB SQ injections

  240 days

• To evaluate satisfaction of 2 LB SQ injections

  240 days

Study Arms (1)

LB 60 mg SQ (70 mg/mL)

EXPERIMENTAL

The participants will receive 2 injections of LB 60 mg SQ (70 mg/mL); 1 at Visit 2 (Day 1) and 1 at Visit 7 (Day 120).

Drug: Levonorgestrel butanoate

Interventions

Levonorgestrel butanoate DRUG

60 mg SQ (70 mg/mL)

Also known as: Chemical, Generic: 13β-ethyl-17α-ethynylgon-4-en-3-one- 17β-n-butyrate, Trade Names: CDB-1830 and HRP002

LB 60 mg SQ (70 mg/mL)

Eligibility Criteria

• Age: 18 Years - 35 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participant understands and signs an ICF approved by the institutional review board prior to any screening activities.
• Female and 18 to 35 years of age, inclusive, at enrollment (Visit 2, Day 1).
• Good general overall health with no chronic medical conditions that result in periodic exacerbations requiring significant medical care.
• Menstrual cycles of 21 to 35 days in length with typical variation in cycle length of 5 days or less when not using hormonal contraception.
• Intact uterus and at least 1 ovary.
• If used a hormonal contraceptive or intra-uterine device (IUD) prior to enrollment, the participant meets the appropriate criteria for time since last use:
• Oral, transdermal, vaginal, copper or LNG IUD or implantable hormonal contraceptives: participants must have discontinued hormone use ≥4 days prior to start of study treatment, experienced bleeding that is consistent with menses in the opinion of the investigator and not have had unprotected intercourse since discontinuing the method.
• Injectable contraception (e.g., DMPA): No injection during the 10 months prior to the Screening Visit, unless the participant has returned to normal menses (i.e., 2 consecutive menses) since last injection.
• Negative urine pregnancy test at enrollment (Visit 2, Day 1).
• Body mass index \<40 kg/m2.
• Willing to use the study method as the primary method of contraception until the end of the Treatment Period.
• At risk for pregnancy defined as:
• Expecting to have ≥1 act of heterosexual intercourse each month during study participation until the end of the Treatment Period.
• No medical history suggesting possible infertility or hypofertility, including but not limited to, ectopic pregnancy or pelvic infection (unless has had a subsequent intra-uterine pregnancy).
• Has a sexual partner with no known problems with infertility orhypofertility.

You may not qualify if:

• Planning pregnancy during study participation through the End -of -Treatment Visit (Visit 11, Day 240).
• Is post-partum and has not had 2 spontaneous menses (1 cycle) since delivery or 1 menses since first or second trimester abortion or miscarriage.
• Breastfeeding or within 30 days of discontinuing breastfeeding unless the participant has already had 2 menses (1 cycle) following discontinuation of breastfeeding.
• Undiagnosed abnormal genital bleeding.
• Undiagnosed vaginal discharge, lesions, or abnormalities.
• Participating in another clinical study involving an IP or device within 30 days prior to the Screening Visit or planning to participate in another clinical study during this study.
• Not living in the catchment area of the study site.
• Known hypersensitivity or contraindication to progestins, including the active substance LB or any excipients of the study treatment.
• Current need for therapeutic anticoagulation or known history of thrombophilia.
• Use or planned use of exogenous reproductive hormones during study participation.
• Body weight change exceeding 10% over the previous year or planned significant weight loss during the study related to bariatric surgery, dieting, or planned treatment.
• Uncontrolled hypertension, in which diastolic blood pressure remains ≥95 mmHg or systolic blood pressure remains ≥145 mmHg.
• Smoking nicotine (e.g., cigarettes or electronic cigarettes) AND has at least 1 of the following comorbidities or conditions (at the discretion of the investigator):
• Current or history of venous thrombophlebitis or thromboembolic disorders (including deep vein thrombosis and pulmonary embolism).
• Current or history of cerebrovascular or coronary-artery disease.

Sponsors & Collaborators

• Premier Research: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

MeSH Terms

Interventions

levonorgestrel butanoate

Study Officials

• Diana Blithe, PhD

  Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  STUDY DIRECTOR

Central Study Contacts

Lauren Schumacher

CONTACT

984-569-6827; Lauren.Schumacher@premier-research.com

Carly Shabshelowitz

CONTACT

919-695-6177; carly.shabshelowitz@premier-research.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Program Director, NICHD

Study Record Dates

• First Submitted: October 22, 2025
• First Posted: October 29, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): March 31, 2029
• Last Updated: October 29, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share