Your session is about to expire
← Back to Search
Progestin
Oral Contraceptive for Birth Control
Phase 3
Waitlist Available
Research Sponsored by Insud Pharma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 6 months and 12 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial will test the contraceptive efficacy, safety, and tolerability of LPRI-CF113 over 12 months, as well as the effect of the medication on bone mineral density in a subgroup of subjects.
Who is the study for?
This trial is for healthy, sexually active females aged 13-45 who are not pregnant or trying to become pregnant and do not plan to use other contraceptives. They must have regular menstrual cycles and a BMI of at least 18 kg/m2. Participants should be willing to engage in intercourse without additional contraception methods and agree to take the study drug for over a year. Those with certain health conditions or taking medications that affect bone density are excluded.
What is being tested?
The trial tests LPRI-CF113's effectiveness as an oral contraceptive (Part A) and its impact on bone mineral density, particularly in the lumbar spine after one year (Part B). It also examines safety and tolerability, along with effects on bone turnover at various body sites.
What are the potential side effects?
While specific side effects aren't listed here, common ones associated with oral contraceptives may include nausea, headaches, mood changes, breast tenderness, weight gain, menstrual changes or irregularities. Safety will be closely monitored throughout the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 6 months and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 6 months and 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Part A (Efficacy Assessment): Number of pregnancies in subjects ≤35 years of age (at the time of screening).
Secondary study objectives
Part A (Efficacy Assessment): Number of pregnancies from exposure cycles in subjects ≤35 years of age.
Part A (Efficacy Assessment): Number of pregnancies from exposure cycles, method failures, and evaluable cycles in all subjects.
Part A (Efficacy Assessment): Number of pregnancies from exposure cycles, method failures, and evaluable cycles in subjects >35 years of age.
+4 moreOther study objectives
Part A (Primary Safety Assessment): Incidence and severity of abnormal bleeding.
Part A (Primary Safety Assessment): Incidence and severity of abnormal cervical cytology.
Part A (Primary Safety Assessment): Incidence and severity of abnormal clinical findings on physical examination, gynecological examination, and transvaginal ultrasound examination.
+13 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Part B - The effect of LPRI-CF113 on bone mineral density in a subgroup age 18-45Experimental Treatment1 Intervention
A subgroup of subjects from Part A that are age 18-45 and without further exclusion criteria to Part B will be enrolled in Part B of the study. Part B of the study will investigate the effects of LPRI-CF113 on bone mineral density.
Group II: Part A - An investigation of the efficacy, safety, and tolerability of LPRI-CF113Experimental Treatment1 Intervention
All subjects enrolled in the study will participate in Part A of the study. Part A of the study will investigate the efficacy, safety, and tolerability of LPRI-CF113.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Drospirenone
2023
Completed Phase 1
~59580
Find a Location
Who is running the clinical trial?
Insud PharmaLead Sponsor
8 Previous Clinical Trials
23,291 Total Patients Enrolled
Chemo ResearchIndustry Sponsor
5 Previous Clinical Trials
3,892 Total Patients Enrolled
Enrico Colli, MDStudy DirectorChemo Research SL
3 Previous Clinical Trials
4,296 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My recent ultrasound showed unusual results.My recent Pap smear showed abnormal cells.I use medications that may affect birth control effectiveness.I want to become pregnant.I had severe COVID-19 or was hospitalized for it within the last 3 months.I have a condition that increases my risk of blood clots.My doctor found something unusual in my physical exam or lab tests.I am willing and able to follow all study rules and visit schedules.I have or am being treated for a specific medical condition.I am willing to take the study drug for about a year and keep a diary.If you are a breastfeeding woman, you can join the study 6 weeks after delivery, regardless of your menstrual cycle.I have a medical condition that is not well-controlled, such as thyroid disorder, without stable treatment for 2+ months.I've used a progestin IUD or implant recently, or taken β-hCG in the last month.I plan to use reliable birth control methods and avoid certain medications during the study.I have never had a menstrual period or my periods have stopped.I am a healthy woman, aged 13-45, able to have children, and at risk of becoming pregnant.I am willing to have unprotected sex with a male partner during the treatment.I stopped using injectable birth control less than 3 months ago.My male partner is infertile or has had a vasectomy or both testicles removed.I have surgery planned that will stop me from using contraceptives.I am not allergic to the ingredients in the study drug LPRI-CF113.Your blood pressure must be below a certain level: 159/99 mmHg or lower.Your blood pressure will be measured three times, and the average of those measurements will be used to determine if you meet this criterion.
Research Study Groups:
This trial has the following groups:- Group 1: Part B - The effect of LPRI-CF113 on bone mineral density in a subgroup age 18-45
- Group 2: Part A - An investigation of the efficacy, safety, and tolerability of LPRI-CF113
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Birth Control Patient Testimony for trial: Trial Name: NCT05461573 — Phase 3
Other Trials to Consider
Popular Categories
Learn More About These Treatments
Share this study with friends
Copy Link
Messenger