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This document provides a summary report of a Phase III clinical trial evaluating the contraceptive efficacy, side effects, and overall acceptability of the once-a-month combined injectable contraceptive
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How to fill out phase iii- clinical trial
How to fill out Phase III- Clinical trial with once a month combined injectable contraceptive Lunelle/Cyclofem
01
Review the trial protocol for Phase III to understand inclusion and exclusion criteria.
02
Obtain informed consent from participants, explaining the purpose and procedures of the trial.
03
Recruit eligible participants who meet the criteria for the trial.
04
Schedule baseline assessments for each participant, including health history and physical examinations.
05
Administer the combined injectable contraceptive Lunelle/Cyclofem to participants on the designated schedule (once a month).
06
Monitor participants for any side effects or adverse reactions after administration.
07
Conduct regular follow-ups to assess the effectiveness of the contraceptive and collect data on any changes in health.
08
Collect and analyze data throughout the trial to evaluate the safety and efficacy of Lunelle/Cyclofem.
Who needs Phase III- Clinical trial with once a month combined injectable contraceptive Lunelle/Cyclofem?
01
Women of reproductive age who are seeking a reliable and convenient contraceptive method.
02
Women who may not be able to use oral contraceptives due to health conditions or personal preferences.
03
Healthcare providers looking to offer new contraceptive options that may enhance patient compliance.
04
Researchers studying the efficacy and safety of monthly injectable contraceptives.
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People Also Ask about
What are the disadvantages of Cyclofemina?
The main disadvantage of both methods is menstrual irregularity. Weight gain and bone pain in DMPA users, while headache and tenderness in Cyclofem users were also observed as the most important side effects.
What is the difference between and Cyclofem?
The biggest difference is that Cyclofem® and Mesigyna® contains estrogen and progestin and ® only has progestin. You have to get a shot once every month with Cyclofem® and Mesigyna®, whereas only once every three months with ®.
What is Cyclofem?
Cyclofem proved its use-effectiveness (pregnancy rate of 0.03%) and its safety under routine service conditions of family planning facilities in Mexico. The overall life table continuation rate at 1 year was 26.1%.
What is the lunelle monthly contraceptive injection?
LUNELLE Monthly Contraceptive Injection is indicated for the prevention of pregnancy. The efficacy of LUNELLE Monthly Contraceptive Injection is dependent on adherence to the recommended dosage schedule (e.g., intramuscular injections every 28 to 30 days, not to exceed 33 days).
Are Depo and Provera the same thing?
Cyclofem is a combined injectable contraceptive, containing medroxyprogesterone acetate (MPA) and cypionate.
What is the name of injectable contraceptive given once in every 3 months?
is a well-known brand name for medroxyprogesterone acetate. It's a birth control shot that has the hormone progestin. A birth control shot is also called a contraceptive injection. People who take get a shot every three months.
How effective is the Cyclofem injection?
Cyclofem proved its use-effectiveness (pregnancy rate of 0.03%) and its safety under routine service conditions of family planning facilities in Mexico. The overall life table continuation rate at 1 year was 26.1%.
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What is Phase III- Clinical trial with once a month combined injectable contraceptive Lunelle/Cyclofem?
Phase III clinical trials for Lunelle/Cyclofem are studies that assess the effectiveness, safety, and optimal dosage of the once-a-month combined injectable contraceptive in a larger population, following initial testing in earlier phases.
Who is required to file Phase III- Clinical trial with once a month combined injectable contraceptive Lunelle/Cyclofem?
The entity sponsoring the clinical trial, typically a pharmaceutical company or research institution, is required to file the necessary documentation for Phase III clinical trials of Lunelle/Cyclofem with regulatory authorities.
How to fill out Phase III- Clinical trial with once a month combined injectable contraceptive Lunelle/Cyclofem?
To fill out Phase III clinical trial documentation for Lunelle/Cyclofem, sponsors need to provide detailed information about the trial design, participant demographics, treatment protocols, safety monitoring plans, and statistical analysis plans.
What is the purpose of Phase III- Clinical trial with once a month combined injectable contraceptive Lunelle/Cyclofem?
The purpose of Phase III trials for Lunelle/Cyclofem is to validate the contraceptive's efficacy and safety in a larger population, assess its real-world applicability, and support the submission for regulatory approval.
What information must be reported on Phase III- Clinical trial with once a month combined injectable contraceptive Lunelle/Cyclofem?
Reports on Phase III clinical trials of Lunelle/Cyclofem must include details such as trial outcomes, side effects, adherence rates, demographic data of participants, statistical findings, and any adverse events encountered during the study.
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