CTI Tracker Glossary
Explore the words and phrases below to support your navigation of the database.
Record Status
Active: Credible evidence of active development or material support for development in the past five calendar years. Credible evidence may be solicited updates from developers, journal publications, verified press releases, developer website updates or media interviews.
- Example: In 2022, a developer publishes a press release announcing a five-year grant supporting animal studies and a Ph I trial for their product.
Inactive: No credible evidence of active development or material support for development in the past five calendar years, or developer confirmation (either in response to solicitation or through publication/the media) that development of a lead or product has ended for scientific, regulatory, or financial reasons.
- Example: The conclusion of a journal publication on a novel contraceptive product states that due to significant safety concerns, the developers will no longer pursue development.
Record Stage
Discovery & Early Development: The Early Development stage includes leads with known biological targets that have not yet entered testing within the scope of Good Laboratory Practice. Activities may include, but are not limited to, evaluation of formulation, stability/degradation, or biocompatibility, proof-of-concept testing, or prototype development. Records in this stage may not yet have a finalized delivery method, and their contraceptive mechanism of action may not yet be confirmed.
Pre-Clinical Development: The Pre-Clinical Development stage includes products that have progressed to in vitro and in vivo testing to assess potential toxicities, establish starting doses for later clinical research, and potentially evaluate drug delivery systems and contraceptive mechanism of action through formalized, regulated research. Results from pre-clinical research may be included in regulatory submissions seeking approval to proceed to clinical development.
Clinical Development: The Clinical Development stage includes products that have received regulatory approval to proceed to human testing. Phases I-III study the safety and effectiveness in humans of a drug, device, or treatment that has not yet received regulatory approval. Phase IV evaluates products that have received regulatory approval.
Single-Country Approval: The Single-Country Approval stage includes products that are available through regulatory approval in only one country. CTI Tracker records in this stage are believed to either be candidates for post-approval clinical research or for re-formulation/re-indication/re-labeling. The Tracker does not monitor products with single-country approval for which no further development is likely (due to safety concerns or low availability/use).
Reproductive System Focus
The CTI Tracker distinguishes between biological sex and gender and recognizes that biological sex itself is also not binary. The terms “male” and “female” are short-hand versions of the below reproductive system definitions and should not be understood to mean “man” and “woman”—the Tracker will not use “male” and “female” to refer to people. Persons of any gender may be potential users for all records listed in the Tracker.
Male Reproductive System: A reproductive system containing a penis, testes and vas deferens
Female Reproductive System: A reproductive system containing a vagina, uterus, fallopian tubes and ovaries
Hormonal/Non-Hormonal
Hormonal: Leads or products containing or targeting hormones involved in the regulation of the hypothalamic-pituitary-gonadal (HPG) axis or the communication between the brain and the ovaries or testes
Non-Hormonal: Leads or products that do not contain or target hormones
Delivery Type/Site
Barrier: Prevents sperm from entering the uterus
Fallopian Tube: Clips or other barriers that are put in or on the fallopian tubes
Injectable: An injection, often intramuscular (IM) or subcutaneous (SC)
Intradermal: Delivered by penetrating the skin, often as a microneedle array patch
Intrauterine: A small device inserted inside the uterus
Oral: Taken by mouth
Subdermal: Placed under the skin, often as polymer capsules or rods
Testicular: Preventing sperm from leaving the testicles
Transdermal: Delivered through the surface of the skin, often as a lotion or gel patch
Vaginal Gel: A film that is placed on or near the cervix by insertion into the vagina
Vaginal Ring: A small, flexible ring that is worn inside the vagina
Vaginal, Other: A vaginal method that is not a gel or ring
Vas Deferens: Interferes with sperm transport in the vas deferens, which carries sperm from the testes
Intended Duration
Permanent: Intended to provide permanent contraception; may be reversible through medical intervention
Long-Acting: Requires administration once per year or less
Short-Acting: Requires administration more than once per year
Pericoital: Used only at the time of sex
Emergency: Used after unprotected sex or method failure
Developer
The organization(s) known to either be actively developing the entry or participated in development in the past, including nonprofits, pharmaceutical companies, universities and other groups in contraceptive R&D. Donors or funders may be included as developers if public information suggests that funder staff served in formal research roles in the development process.
Active Pharmaceutical Ingredient (API)
The chemical ingredient or material in a pharmaceutical drug or device that is biologically active and causes the contraceptive effect. If non-contraceptive APIs are included in a record, they will be identified as such; this is most relevant for multi-purpose prevention technologies.
Inactive Material
The ingredient or material in a pharmaceutical drug or device that is not biologically active and does not cause the contraceptive effect.
Target
The molecule or cellular component to which another entity, typically the API, is directed or binds, resulting in a physiological change.
Mechanism of Action
The mechanism through which the lead or product is understood to prevent pregnancy. For early-stage records, this may not yet be scientifically evaluated.
Regimen
The frequency and interval at which the product is used. This may not be finalized prior to late-phase clinical research.
Multi-Purpose Prevention Technology (MPT)
A single preventative product that allows users to address multiple sexual and reproductive health risks, such as preventing pregnancy and protecting against transmission of HIV. Barrier methods that reliably prevent the transmission of disease can be considered MPTs.
Promising Attributes/Potential Impact
Attributes of the lead or product that suggest it may be a viable or beneficial development platform or may have a positive public health impact. These attributes should not be considered scientifically confirmed or independently verified; they solely reflect the goals and intentions of the developers as stated in publicly available sources, and general knowledge about the global contraceptive market.
Publications
Published literature documenting development milestones for each record.
Additional Information
Grey literature and credible supplementary information documenting development milestones for each record.
Not Yet Determined vs Undetermined
"Not Yet Determined" indicates that information is currently unknown, but as the lead or product is under active development, it may be determined in the future. "Undetermined" indicates that the information remained unknown up until the point that development of the lead or product ended, and will likely not be determined unless the development platform is re-activated.
Have Questions or Suggestions?
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