Description
The purpose of this guidance is to assist sponsors in developing drugs for the treatment of low sexual interest, desire, and/or arousal in women. Specifically, this guidance addresses the Food and Drug Administration’s (FDA’s) current thinking regarding the overall clinical development program, with a focus on phase 3 trial designs, to support an indication for the treatment of these conditions. This draft guidance is intended to serve as a focus for continued discussions among the Division of Bone, Reproductive, and Urologic Products, pharmaceutical companies, the academic community, and the public.
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
1references to drugs include both human drugs and therapeutic biological products
Stakeholders
2responsible for justifying omission of studies
sponsors can request a full waiver for pediatric studies
Regulatory Context
Regulatory Activities
3focus on phase 3 trial designs to support an indication
Guidance describes recommendations regarding phase 3 trials for prescription non-opioid analgesic products.
framework for collaboration on PRO instruments
Document Types
4Clinical outcome assessment tool used to collect patient data.
providing reminders to trial subjects to complete PRO instruments
Records kept in electronic format subject to specific requirements.
Patient-reported outcome instrument used for primary endpoints in phase 3 trials
Attributes
3evidence that the items and domains of an instrument are appropriate; FDA concerns with the content validity and response scale of the FSFI desire domain
long recall period (28 days) as discussed in section III.D.1
plan for controlling type I error for endpoints leading to labeling claims
Technical Details
Testing Methods
6Instrument for measuring patient-reported outcomes; 19-item instrument used in clinical trials to measure overall sexual function
Instrument for measuring patient-reported outcomes
a statistical methodology for dose response
instrument considered acceptable for measuring bother related to decreased sexual desire
static current-state anchor to evaluate the responder definition
anchor used in addition to the PGI-S to provide evidence in interpreting change
Processes
1Development programs for all new molecular entities should include this assessment
Clinical Concepts
8FSIAD is a clinical entity described in the DSM-5
HSDD is a condition described in the fourth edition of the DSM
FSAD is a condition described in the fourth edition of the DSM
guidance does not address the treatment of dyspareunia
often related to VVA associated with menopause
can adversely affect various aspects of life for a woman
Female Sexual Interest/Arousal Disorder
prospective assessment for drugs with a potential psychotropic mechanism
Standards & References
External Standards
1Used to define symptoms of MDD.
ICH References (5)
Statistical Principles for Clinical Trials; Discourages deterministic procedures due to high risk of bias; Notes that the use of Bayesian methods in clinical trials may be considered.
Choice of Control Group in Clinical Trials.
Dose-Response Information to Support Drug Registration
Regulatory standards for the extent of population exposure for treatments intended for long-term treatment
Clinical Evaluation of QT/QTc Interval Prolongation.
Related CFR Sections (3)
- 21CFR300.50§ 300.50 Fixed-combination prescription drugs for humans.
The Food and Drug Administration's policy in administering the new-drug, antibiotic, and other regulatory provisions of the Federal Food, Drug, and Cosmetic Act regarding fixed combination dosage form prescription drugs for humans is as follows:Read full regulation →
- 21CFR314.50§ 314.50 Content and format of an NDA.
NDAs and supplements to approved NDAs are required to be submitted in the form and contain the information, as appropriate for the particular submission, required under this section. Three copies of the NDA are required: An archival copy, a review copy, and a field copy. An NDA for a new chemical enRead full regulation →
- 21CFR314.126§ 314.126 Adequate and well-controlled studies.
(a) The purpose of conducting clinical investigations of a drug is to distinguish the effect of a drug from other influences, such as spontaneous change in the course of the disease, placebo effect, or biased observation. The characteristics described in paragraph (b) of this section have been develRead full regulation →
See Also (8)
- Obesity and Overweight: Developing Drugs and Biological Products for Weight Reduction (Status: Draft)
- Study of Sex Differences in the Clinical Evaluation of Medical Products (Status: Draft)
- Format and Content of the Clinical and Statistical Sections of an Application (Status: Final)
- Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products — Content and Format: Guidance for Industry (Status: Final)
- Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document (Status: Final)
- Integrated Summary of Effectiveness (Status: Final)
- Rare Diseases: Natural History Studies for Drug Development: Draft Guidance for Industry (Status: Draft)
- Upper Facial Lines: Developing Botulinum Toxin Drug Products (Status: Draft)