Description
This guidance provides recommendations for clinical trials designed to establish clinical effectiveness and safety for hormonal drug products intended to prevent pregnancy . Drug product development in hormonal contraception has evolved over the years, especially with the development of lower-dose hormonal drug products and longer-acting reversible contraceptives. Changes in patient demographics, pregnancy testing, determinations of conception date, and dosing directions have also occurred. This guidance reflects these developments and is generally consistent with advice we have been providing to individual sponsors developing hormonal drug products.
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
4Two phase 3 trials may be recommended.
May conduct a single phase 3 trial for these products.
evolution of drug product development in hormonal contraception; Trials of longer duration recommended for these systems.
intended to prevent pregnancy
Stakeholders
2Entity responsible for submitting applications under section 524B
Assist sponsors in the nonclinical evaluation
Regulatory Context
Regulatory Activities
2May be required for risks like venous thromboembolism.
Development program for drugs intended for sGERD treatment
Document Types
2Subjects should complete to capture vaginal intercourse and contraceptive use.
Cybersecurity information should be included in device labeling
Attributes
3Body Mass Index used for weight classification and estimating adiposity
definition of obese women for trial population
effectiveness of some contraceptives may be reduced with increasing body weight
Technical Details
Substances
2Example of long-acting injectable contraceptive.
Drug type that may alter the minimum acceptable size of the safety database
Testing Methods
6Supportive analysis to provide monthly and cumulative failure rates.
Performed for dating if pregnancy is confirmed.
Used to confirm positive urine pregnancy tests.
Performed regularly at clinic visits.
generally sufficient to establish efficacy
prespecified analysis in the obese population
Processes
2Sponsors encouraged to conduct for new drug products.
developments in drug product development
Clinical Concepts
7Defined as pregnancy occurring during use or within specific timeframe after last use.
screening criteria for enrollment
screening criteria for enrollment
subjects likely to use the drug product
defined as BMI of at least 30 kg/m2
recommended enrollment criteria for clinical trials
Example of a condition to be captured in the medical history section.
Identified Hazards
Hazards
1Infrequent but well-known risk of hormonal contraceptives.
Standards & References
Specifications
2the lower bound of the one-sided 95% confidence interval (CI) must be above 0 ms.; statistical metric for demonstrating independence of QTc to RR
Primary efficacy endpoint defined as number of pregnancies per 100 woman-years.
Related MFDS Guidelines
Korean regulatory guidelines covering similar topics
See Also (8)
- DSCSA Implementation: Product Tracing Requirements — Compliance Policy
- E6(R3) Good Clinical Practice: Annex 2
- Consumer Antiseptic Rub Final Rule Questions and Answers Guidance for Industry: Guidance for Industry
- Best Practices for Communication Between IND Sponsors and FDA During Drug Development
- Botanical Drug Development: Guidance for Industry
- Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry
- Reformulating Drug Products That Contain Carbomers Manufactured With Benzene
- ANDA Submissions -- Refuse-to-Receive Standards Rev.2