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Depot-Leuprolide/Norethindrone
Leuprolide suppresses gonadotropin-releasing hormone (GnRH) signaling to reduce sex hormone production, while norethindrone provides progestin supplementation to prevent estrogen-induced side effects.
Leuprolide suppresses gonadotropin-releasing hormone (GnRH) signaling to reduce sex hormone production, while norethindrone provides progestin supplementation to prevent estrogen-induced side effects. Used for Endometriosis, Uterine fibroids (leiomyomata), Central precocious puberty.
At a glance
| Generic name | Depot-Leuprolide/Norethindrone |
|---|---|
| Sponsor | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| Drug class | GnRH agonist with progestin co-therapy |
| Target | GnRH receptor (leuprolide component); progesterone receptor (norethindrone component) |
| Modality | Small molecule |
| Therapeutic area | Endocrinology / Reproductive Health |
| Phase | Phase 3 |
Mechanism of action
Leuprolide is a GnRH agonist that initially stimulates then desensitizes GnRH receptors, leading to sustained suppression of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), thereby reducing ovarian estrogen and androgen production. Norethindrone, a synthetic progestin, is co-administered to prevent hypoestrogenic symptoms (hot flashes, bone loss) and maintain endometrial stability during prolonged GnRH agonist therapy.
Approved indications
- Endometriosis
- Uterine fibroids (leiomyomata)
- Central precocious puberty
Common side effects
- Hot flashes
- Headache
- Mood changes / depression
- Vaginal dryness
- Injection site reactions
- Bone density loss
Key clinical trials
- Medical Treatment of Endometriosis-Associated Pelvic Pain (PHASE3)
- Treatment of Endometriosis With Norethindrone Acetate ( NA) VS. Gonadotropin- Releasing Hormone (GnRH) Agonist (Lupron Depot 11.25 mg) (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |