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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age between 18 and 40 years inclusive at the injection visit
Intact uterus with at least one ovary
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0, 2, 4, 6, 8, 24, 48, 96, 168, and 240 hours. then weekly for up to 26 weeks.
Awards & highlights
Study Summary
This trial is testing a new injectable drug, given either under the skin or into muscle. Two different doses are being studied to see what effect it has on the body, and how well it is absorbed and used.
Who is the study for?
Healthy women aged 18-40 with a BMI under 40, regular menstrual cycles, and no chronic medical conditions. They must not be at risk for pregnancy during the study, have an intact uterus with at least one ovary, and agree to use non-hormonal contraception if sexually active. Exclusions include hypersensitivity to progestins, drug abuse, uncontrolled thyroid disorders, cardiovascular diseases or thrombosis risks.Check my eligibility
What is being tested?
The trial is testing Levonorgestrel Butanoate (LB) injections as a method of birth control in healthy women. It's an open-label study where participants receive three different doses (40 mg IM followed by 50mg SQ then potentially increasing to 60 mg SQ), depending on initial results.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site such as pain or swelling, hormonal changes that could affect mood or weight, headaches, nausea or other digestive issues. Since it's a contraceptive trial involving hormones, there might also be changes in menstrual cycle patterns.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 40 years old.
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I have a uterus and at least one ovary.
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My progesterone level is above 3 ng/ml, confirming I ovulate.
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I am generally healthy without chronic conditions needing frequent medical care.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0, 2, 4, 6, 8, 24, 48, 96, 168, and 240 hours. then weekly for up to 26 weeks.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0, 2, 4, 6, 8, 24, 48, 96, 168, and 240 hours. then weekly for up to 26 weeks.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Measurement of levonorgestrel serum concentrations
Secondary outcome measures
Bleeding patterns (spotting and light, moderate or heavy bleeding) reported through weekly subject diaries
Gonadotropin (Follicle Stimulating Hormone and Luteinizing Hormone) concentrations
Measurement of Endometrial thickness
+4 moreTrial Design
5Treatment groups
Experimental Treatment
Group I: LB injection 60mg Subcutaneous (SQ) with 70 mg/ml concentrationExperimental Treatment1 Intervention
32 subjects (16 with BMI <30mg^2; 16 with BMI >=30kg/m^2 and <40kg/m^2) will be administered a single dose of levonorgestrel butanoate (LB) injection 60mg subcutaneous (SC) using 70 mg/ml concentration
Group II: LB injection 50mg subcutaneous (SQ) with 70 mg/ml concentrationExperimental Treatment1 Intervention
8 subjects (8 with BMI <40 kg/m2) will be administered a single dose of levonorgestrel butanoate (LB) injection 50mg intramuscular (IM) using 70 mg/ml concentration
Group III: LB injection 40mg intramuscular (IM) with 20 mg/ml concentrationExperimental Treatment1 Intervention
27 subjects (18 with BMI <30mg^2; 9 with BMI >=30kg/m^2 and <40kg/m^2) were administered a single dose of levonorgestrel butanoate (LB) injection 40mg intramuscular (IM) using 20 mg/ml concentration
Group IV: LB injection 40 mg subcutaneous (SQ) with 70 mg/ml concentrationExperimental Treatment1 Intervention
32 subjects (21 with BMI <30mg^2; 11 with BMI >=30kg/m^2 and <40kg/m^2) were administered a single dose of levonorgestrel butanoate (LB) injection 40mg subcutaneous (SC) using 70 mg/ml concentration
Group V: LB injection 40 mg subcutaneous (SC) with 20 mg/ml concentrationExperimental Treatment1 Intervention
32 subjects (25 with BMI <30mg^2; 7 with BMI >=30kg/m^2 and <40kg/m^2) were administered a single dose of levonorgestrel butanoate (LB) injection 40mg subcutaneous (SC) using 20 mg/ml concentration
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Health DecisionsLead Sponsor
30 Previous Clinical Trials
13,761 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,964 Previous Clinical Trials
2,674,594 Total Patients Enrolled
Diana BlitheStudy DirectorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1 Previous Clinical Trials
1,000 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My recent Pap test results meet the required guidelines and no further treatment is needed.I've used long-acting birth control injections in the last 9 months but had at least one normal period since.I am related or close to someone who works on the study.I have had at least 2 menstrual cycles since giving birth or having a second-trimester abortion.I have had blood clots in my veins.I am between 18 and 40 years old.I have had at least one complete menstrual cycle since stopping hormonal birth control.I am not on medications that affect birth control or are unsafe in pregnancy.I have no undiagnosed vaginal issues, or if diagnosed with Chlamydia or gonorrhea, I have completed treatment.I have a history of blood clotting disorders.I am not at risk of becoming pregnant during the study.I am HIV positive.I need hormone therapy or blood thinners for my condition.You are currently using a copper intrauterine device (IUD) for birth control.Your body mass index (BMI) is less than 40 kg/m2.I have a uterus and at least one ovary.I smoke more than 15 cigarettes a day or use more than 1 ml/day of e-cigarette liquid.I am willing to keep a daily diary for the study.My progesterone level is above 3 ng/ml, confirming I ovulate.I have or might have cancer that grows with hormones, like breast or uterine cancer.I have unexplained bleeding from my genital area.I haven't taken any medication from the Exclusionary List in the last 90 days.I am generally healthy without chronic conditions needing frequent medical care.You have a known allergy or medical condition that prevents you from taking progestins.I am a woman planning major surgery while in the study.You have a problem with alcohol or drug addiction that could affect how the study drug works or your ability to follow the study instructions.You are allergic to the main ingredient or other ingredients of the study treatment.I have been cancer-free (except for basal cell carcinoma) for over 5 years.My weight has changed by more than 10% in the last year or I plan to lose a significant amount of weight during the study.I am currently using hormonal birth control.My thyroid disorder is not under control.I have heart or blood vessel disease, or a high risk of blood clots in arteries.My liver is not functioning properly, with tests showing high levels.I have not been in a drug/device trial in the last 3 months and won't join another during this study.
Research Study Groups:
This trial has the following groups:- Group 1: LB injection 40 mg subcutaneous (SQ) with 70 mg/ml concentration
- Group 2: LB injection 40 mg subcutaneous (SC) with 20 mg/ml concentration
- Group 3: LB injection 50mg subcutaneous (SQ) with 70 mg/ml concentration
- Group 4: LB injection 60mg Subcutaneous (SQ) with 70 mg/ml concentration
- Group 5: LB injection 40mg intramuscular (IM) with 20 mg/ml concentration
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the scope of recruitment for this experiment?
"This clinical trial requires 160 suitable participants, who meet the predetermined eligibility criteria. Those interested can join at any of the two available sites; University of Utah in Salt Lake City and Comprehensive Women's Health Center in Denver, Colorado."
Answered by AI
Are there any North American centers involved in conducting the clinical trial?
"At present, seven clinical trial sites are operational for this medical experiment. This includes the University of Utah in Salt Lake City, Comprehensive Women's Health Center in Denver and Boston Medical Center Corporation in Boston, as well as four additional locations."
Answered by AI
Are there any remaining slots available for enrollees in this experiment?
"Affirmative, clinicaltrials.gov reflects that this ongoing trial is still recruiting participants; it was first made public on March 3rd 2020 and has been amended as recently as November 16th 2022. Approximately 160 individuals need to be enrolled from 7 different medical centres."
Answered by AI
Does this clinical trial accept participants aged 70 or above?
"This medical study is open to patients who are of legal age and no more than 40 years old."
Answered by AI
Does the FDA sanction levonorgestrel butanoate (LB) injection?
"Due to the limited data confirming levonorgestrel butanoate (LB) injection's efficacy and safety, our team at Power rated it a 1 on the risk scale."
Answered by AI
Do I satisfy the criteria for enrollment in this investigation?
"Qualified individuals must be within the age parameters of 18 to 40 and have reliable female contraception. This clinical trial is seeking approximately 160 participants."
Answered by AI
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