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Also known as Transdermal system containing progestin
system containing progestin · 1 trial · 1 indication
The primary efficacy endpoint will be pregnancy rate described by Pearl Index (PI). PI is defined as the number of pregnancies per 100 women-years.
| Arm | Type | Description |
|---|---|---|
| This is a single-arm study. | EXPERIMENTAL | The study patch is a transdermal system that contains the active ingredient progestin. This study is an open-label, single-arm study. This means that all participants in the study will receive the study patch |
| Name | Type | Description |
|---|---|---|
| Transdermal system containing progestin | DRUG | MR-130A-01 transdermal system, patch to be used for female contraception |
Inclusion Criteria: 1. Healthy, post-menarcheal and premenopausal women at risk of pregnancy who are at least 16 years of age. 2. Desires to avoid pregnancy, is seeking to use hormonal contraception for at least 1 year. 3. Has negative UPT results at screening and at enrollment visits. 4. Has norma...
The transdermal system containing progestin is an investigational contraceptive patch being developed for female contraception. It is a small molecule therapy delivered through the skin and is designed as a progestin-only option for women of childbearing potential. Viatris Inc. is developing the product, which is currently in Phase 3 clinical development.
The transdermal system containing progestin is being developed for female contraception in women of childbearing potential. Its Phase 3 trial is evaluating contraceptive efficacy and safety in this population. The product is investigational and has not been approved for marketing.
The transdermal system containing progestin targets the progesterone receptor, abbreviated PR. Binding to the progesterone receptor is the mechanism by which progestin-based contraceptives suppress ovulation and thicken cervical mucus. The patch delivers a progestin through the skin into the bloodstream.
Viatris Inc., which trades on Nasdaq under the ticker VTRS, is developing the transdermal system containing progestin. Viatris is the sponsor of the Phase 3 contraceptive efficacy and safety study of the progestin-only patch.
The transdermal system containing progestin is in Phase 3 clinical development. It is investigational and has not been approved by the FDA. The single Phase 3 trial is active but no longer recruiting participants.
The transdermal system containing progestin is being studied in NCT06672016, titled Study to Evaluate Contraceptive Efficacy and Safety of a Progestin Only Patch in Women of Childbearing Potential. The Phase 3 trial has enrolled 1,630 female participants aged 16 years and older in the United States and is active but not recruiting.
Yes. The transdermal system containing progestin is also known as the transdermal system containing progestin, and it is described in its Phase 3 trial as a progestin-only patch. These names refer to the same investigational contraceptive product developed by Viatris Inc.