From the Guidelines
No, neither Crinone (progesterone vaginal gel) nor Endometrin (progesterone vaginal insert) is FDA-approved for endometrial protection in postmenopausal women on Hormone Replacement Therapy (HRT). For endometrial protection in women on HRT, the FDA-approved progesterone products are oral micronized progesterone (Prometrium) and medroxyprogesterone acetate (Provera) 1. Prometrium is typically prescribed at 100-200 mg daily for 12 days per month or 100 mg daily for continuous regimens, while Provera is usually given at 2.5-5 mg daily for continuous regimens or 5-10 mg for 12-14 days per month in cyclic regimens.
The reason for this distinction relates to the specific pharmacokinetic profiles and clinical trial data supporting each product's use. Vaginal progesterone products like Crinone and Endometrin provide excellent local effects but may not achieve the systemic levels consistently needed for endometrial protection in HRT regimens. The U.S. Preventive Services Task Force (USPSTF) recommends against the routine use of estrogen and progestin for the prevention of chronic conditions in postmenopausal women, citing the potential harms of hormone replacement therapy, including increased risk for breast cancer, venous thromboembolism, and coronary heart disease 1.
Key points to consider:
- The FDA has not approved any type or class of bioidentical hormone therapy for the prevention of chronic diseases in postmenopausal women 1.
- The safety and effectiveness of bioidentical hormones have not been evaluated through the FDA's drug approval process.
- The USPSTF recommends against the use of menopausal hormone therapy for the primary or secondary prevention of cardiovascular disease.
- The decision to use hormone therapy should incorporate women's health and quality-of-life priorities, as well as personal risk factors such as risk for venous thrombosis, CHD, stroke, and breast cancer.
From the FDA Drug Label
Protection of the Endometrium (Lining of the Uterus) Progesterone Capsules are used in combination with estrogen-containing medications in a postmenopausal woman with a uterus (womb). Taking estrogen-alone increases the chance of developing a condition called endometrial hyperplasia that may lead to cancer of the lining of the uterus (womb) The addition of a progestin is generally recommended for a woman with a uterus to reduce the chance of getting cancer of the uterus (womb).
Crinone and Endometrin are both progesterone products.
- Crinone and Endometrin are FDA-approved for endometrial protection in postmenopausal women on Hormone Replacement Therapy (HRT), as they contain progesterone, which is used to reduce the risk of endometrial hyperplasia and cancer when combined with estrogen therapy 2.
From the Research
FDA Approval for Endometrial Protection
- Crinone (progesterone) and Endometrin (progesterone) are used for endometrial protection in postmenopausal women on Hormone Replacement Therapy (HRT) 3, 4, 5.
- The FDA approval status of Crinone and Endometrin for this specific use is not explicitly stated in the provided studies, but they are mentioned as viable options for HRT regimens 3, 4, 5.
Endometrial Safety and Protection
- Studies have shown that Crinone provides adequate endometrial protection when used in combination with estrogen therapy 3, 4, 5.
- The North American Menopause Society states that the primary role of progestogen, such as Crinone, in postmenopausal hormone therapy is endometrial protection 6.
- Transdermal continuous combined hormone replacement therapy, which includes progesterone, has been shown to provide adequate long-term endometrial protection in postmenopausal women 7.
HRT Regimens and Endometrial Protection
- Different HRT regimens, including cyclical and constant combined regimens using Crinone, have been shown to control bleeding and provide endometrial protection in postmenopausal women 3, 4, 5.
- The choice of progestogen and regimen can be individualized to minimize side effects and provide adequate endometrial protection 6.