Healthy WomenPhase 2NCT07222228
A Study to Evaluate the Efficacy and Safety of Subcutaneous Levonorgestrel Butanoate for Female Contraception
A Phase 2 study testing Levonorgestrel butanoate in people with Healthy Women and Female Contraception, run by Premier Research.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Women, Female Contraception
- What is being tested?
- Levonorgestrel butanoate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 31 Mar 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
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- 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.
- Valvular heart disease with thrombogenic complications.
- Diabetes with vascular involvement.
- Known inherited or acquired predisposition to venous thromboembolism or arterial thromboembolism (e.g., factor VLeiden, prothrombin mutation, antiphospholipid antibodies) or bruising within the last 12 months prior to consent.
- Current or past cerebrovascular or cardiovascular disease or at risk of clotting disorders.
- Impaired mobility (e.g., is wheelchair bound or bedridden) that, in the investigator's opinion, places the participant at increased risk of thrombosis.
- Known or suspected carcinoma of the breast or suspected progestin-dependent neoplasia.
- Known or suspected pelvic organ carcinoma.
- Known Papanicolaou (Pap) or human papillomavirus (HPV) test abnormality that would require a repeat evaluation or treatment during study participation based on standard of care guidelines (American Society for Colposcopy and Cervical Pathology or American College of Obstetricians and Gynecologists).
- Known benign or malignant liver tumors, renal disease, or active liver disease.
- Invasive cancer (past history of any carcinoma or sarcoma, except non-melanoma skin cancer) unless in remission for >5 years.
- Current or past medically diagnosed severe depression, which, in the investigator's opinion, could be exacerbated by use of a hormonal contraceptive, unless participant is on stable antidepressant medication.
- Known or suspected current alcohol dependence syndrome or any recreational drug use that may affect metabolism of the IP or study compliance.
- Abnormal screening laboratory values defined as:
- Fasting clinical chemistry values or CBC values designated clinically significant by the investigator.
- Liver function test results >twice the upper limit of normal.
- Uncontrolled thyroid disorder.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 2b Study to Evaluate the Efficacy and Safety of Subcutaneous Levonorgestrel Butanoate for Female Contraception
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.
Read the detailed description
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. The study plans to enroll approximately 165 female participants, 18 to 35 years of age, inclusive, at enrollment (Visit 2, Day 1), who have good general overall health. They also must have menstrual cycles of 21 to 35 days when not using hormonal contraception with typical variation in cycle length of 5 days or less, have an intact uterus and at least 1 ovary, expect to have heterosexual intercourse at least once per month during the study, and agree to use no additional methods of contraception during the study. Participants will be excluded if they are planning pregnancy during study participation through the End-of-Treatment Visit (Visit 11, Day 240). In addition, participants must have had 2 spontaneous menses (1 cycle) since delivery, 1 menses following first or second trimester abortion or miscarriage, must not be breastfeeding, or be within 30 days of discontinuing breastfeeding unless the participant has already had 1 cycle (2 menses) following discontinuation of breastfeeding.
The primary aim of the study is to evaluate the contraceptive efficacy of LB SQ injections over 8 cycles. Additionally, LB safety will be assessed based on the incidence of AEs (including weight increase) and injection site reactions and changes from baseline laboratory parameters. The number of bleeding and spotting days per 30-, 90-, and 120-day intervals, as well as responses from the acceptability and satisfaction questionnaire at Day 240 (Month 8), are also secondary endpoints of the study.
- Conditions
- Healthy Women, Female Contraception
- Being tested
- Levonorgestrel butanoate
- Keywords
- Female contraception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levonorgestrel butanoateDrug
Also called Chemical, Generic: 13β-ethyl-17α-ethynylgon-4-en-3-one- 17β-n-butyrate, Trade Names: CDB-1830 and HRP002
60 mg SQ (70 mg/mL)
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Levonorgestrel butanoate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 224 days
Secondary outcomes (5)
To assess the safety of 2 LB SQ injections
To assess the safety of 2 LB SQ injections as measured by:
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
Measured: 240 days
To further explore the contraceptive efficacy of 2 LB SQ injections
To further explore the contraceptive efficacy of 2 LB SQ injections as measured by the Pearl Index through 8 cycles
Measured: 224 days
To explore bleeding patterns in participants receiving 2 LB SQ injections
To explore bleeding patterns in participants receiving 2 LB SQ injections as measured by Number of bleeding and spotting days per 30-, 90-, and 120-day intervals
Measured: 240 days
To evaluate acceptability of 2 LB SQ injections
To evaluate acceptability of 2 LB SQ injections as measured by the number and percentage of subjects that provide each response to a given question related to acceptability on the CCN021b Acceptability and Satisfaction Questionnaire responses at 8 months.
Questions range from 'Definitely No' to 'Definitely Yes'.
Measured: 240 days
To evaluate satisfaction of 2 LB SQ injections
To evaluate satisfaction of 2 LB SQ injections as measured by the number and percentage of subjects that provide each response to a given question related to satisfaction on the CCN021b Acceptability and Satisfaction Questionnaire responses at 8 months.
Questions range from 'Very Satisfied' to 'Very Unsatisfied' and 'Strongly Agree' to 'Strongly Disagree'.
Measured: 240 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2025
- Study start1 Apr 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Premier Research
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Clint Dart, Premier Research
- Investigators
- Diana Blithe, PhD, Study director, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07222228
- Sponsor's protocol ID
- CCN021B
- Status last verified
- Oct 2025
- First submitted
- 22 Oct 2025
- Last updated
- 29 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b Study to Evaluate the Efficacy and Safety of Subcutaneous Levonorgestrel Butanoate for Female Contraception
- ClinicalTrials.gov ID
- NCT07222228
- Acronym / sponsor ID
- CCN021B
- Conditions
- Healthy Women, Female Contraception
- Keywords
- Female contraception
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Premier ResearchUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 29 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. The study plans to enroll approximately 165 female participants, 18 to 35 years of age, inclusive, at enrollment (Visit 2, Day 1), who have good general overall health. They also must have menstrual cycles of 21 to 35 days when not using hormonal contraception with typical variation in cycle length of 5 days or less, have an intact uterus and at least 1 ovary, expect to have heterosexual intercourse at least once per month during the study, and agree to use no additional methods of contraception during the study. Participants will be excluded if they are planning pregnancy during study participation through the End-of-Treatment Visit (Visit 11, Day 240). In addition, participants must have had 2 spontaneous menses (1 cycle) since delivery, 1 menses following first or second trimester abortion or miscarriage, must not be breastfeeding, or be within 30 days of discontinuing breastfeeding unless the participant has already had 1 cycle (2 menses) following discontinuation of breastfeeding.
The primary aim of the study is to evaluate the contraceptive efficacy of LB SQ injections over 8 cycles. Additionally, LB safety will be assessed based on the incidence of AEs (including weight increase) and injection site reactions and changes from baseline laboratory parameters. The number of bleeding and spotting days per 30-, 90-, and 120-day intervals, as well as responses from the acceptability and satisfaction questionnaire at Day 240 (Month 8), are also secondary endpoints of the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LB 60 mg SQ (70 mg/mL) | Experimental | Drug: Levonorgestrel butanoateThe 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). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (31 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levonorgestrel butanoateAlso: Chemical, Generic: 13β-ethyl-17α-ethynylgon-4-en-3-one- 17β-n-butyrate, Trade Names: CDB-1830 and HRP00260 mg SQ (70 mg/mL) | Drug | LB 60 mg SQ (70 mg/mL) |
Primary outcome
To evaluate the contraceptive efficacy of 2 LB SQ injections administered at a 4-month (approximately 17 weeks)interval over 8 cycles
Time frame: 224 days
As measured by The cumulative pregnancy percentage (calculated using Kaplan-Meier) through 8 cycles
5 secondary outcomes
To assess the safety of 2 LB SQ injections
Time frame: 240 days
To further explore the contraceptive efficacy of 2 LB SQ injections
Time frame: 224 days
To explore bleeding patterns in participants receiving 2 LB SQ injections
Time frame: 240 days
To evaluate acceptability of 2 LB SQ injections
Time frame: 240 days
To evaluate satisfaction of 2 LB SQ injections
Time frame: 240 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Diana Blithe, PhD study director
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Levonorgestrel butanoate in people with Healthy Women and Female Contraception, run by Premier Research.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lauren Schumacher (984-569-6827, Lauren.Schumacher@premier-research.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the contraceptive efficacy of 2 LB SQ injections administered at a 4-month (approximately 17 weeks)interval over 8 cycles (time frame: 224 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2025.