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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
Study 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part A (Efficacy Assessment): Number of pregnancies in subjects ≤35 years of age (at the time of screening).
Secondary outcome measures
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 outcome measures
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 moreSide effects data
From 2017 Phase 3 trial • 1552 Patients • NCT022692415%
Metrorrhagia
5%
Headache
4%
Breast pain
4%
Dysmenorrhoea
4%
Nausea
3%
Breast tenderness
3%
Acne
2%
Menorrhagia
2%
Weight increased
1%
Vaginal haemorrhage
1%
Amenorrhoea
1%
Abdominal distension
1%
Vomiting
1%
Migraine
1%
Alopecia
1%
Mood swings
1%
Menstruation irregular
1%
Abdominal pain
1%
Depression
1%
Affect lability
1%
Vulvovaginal mycotic infection
1%
Decreased appetite
1%
Libido decreased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Drospirenone 4mg
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
~59530
Find a Location
Who is running the clinical trial?
Insud PharmaLead Sponsor
8 Previous Clinical Trials
23,291 Total Patients Enrolled
Chemo ResearchIndustry Sponsor
4 Previous Clinical Trials
3,672 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:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
Birth Control Patient Testimony for trial: Trial Name: NCT05461573 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the likelihood that Drospirenone will cause health complications?
"Drospirenone is a Phase 3 drug, so it has some evidence of efficacy and multiple rounds of safety data, giving it a score of 3 on our team's scale."
Answered by AI
Does this research project consider young adults in its parameters?
"According to the specific eligibility requirements detailed for this clinical trial, applicants must be aged between 13 and 45. There are 23 studies available for those under 18 years old and 16 studies available if the patient is over 65."
Answered by AI
Could you inform me about availability for this treatment program?
"Yes, the trial is recruiting patients as indicated by information on clinicaltrials.gov. The listing was created on 8/2/2022 and updated on 11/4/2022. They are seeking 1009 individuals from 11 different hospitals or clinics."
Answered by AI
Are there any specific requirements for individuals who want to enroll in this clinical test?
"This medical trial is looking for 1009 patients that meet the following criteria: -Between the ages of 13 and 45 -Currently using contraception -Willing to provide written consent -Female -Healthy -Sexually active -Of childbearing potential -(For subjects 18 to 45 years of age) Systolic blood pressure must be less than 159 mmHg and diastolic blood pressure must be less than 99 mmHg -(For women 6 weeks postpartum) Breastfeeding does not exclude a subject from participation if they are otherwise eligible"
Answered by AI
Who else is applying?
What state do they live in?
North Carolina
Texas
What site did they apply to?
TMC Life Research
Florida International Medical Research
Chattanooga Medical Research
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
To learn if there is a birth control that works for me. I am looking for a birth control that works for my body.
PatientReceived 2+ prior treatments
Recent research and studies
The LancetJournal
Nuisance or Natural and Healthy: Should Monthly Menstruation Be Optional for Women?Other Trials to Consider
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