Last reviewed 2026-04-20 · How we verify

Endometrin (progesterone)

At a glance

Approved indications

• Amenorrhea Secondary to Ovarian Dysfunction
• Atrophic vaginitis
• Contraception
• Corpus Luteum Insufficiency Syndrome
• Dysfunctional uterine bleeding
• Endometrial Hyperplasia Prevention
• Endometrial carcinoma
• Endometriosis
• Infertility Secondary to Progesterone Deficiency
• Menopausal flushing
• Postmenopausal osteoporosis
• Prevention of Premature Labor
• Secondary malignant neoplasm of kidney
• Secondary physiologic amenorrhea

Boxed warnings

• WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA FOR ESTROGEN PLUS PROGESTIN THERAPY Cardiovascular Disorders and Probable Dementia Estrogens plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia. (See CLINICAL STUDIES and WARNINGS , Cardiovascular disorders and Probable dementia . ) The Women's Health Initiative (WHI) estrogen plus progestin substudy reported increased risks of deep vein thrombosis, pulmonary embolism, stroke and myocardial infarction in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg] combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo. (See CLINICAL STUDIES and WARNINGS , Cardiovascular disorders . ) The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women. (See CLINICAL STUDIES and WARNINGS, Probable dementia and PRECAUTIONS, Geriatric Use . ) Breast Cancer The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer. (See CLINICAL STUDIES and WARNINGS, Malignant neoplasms, Breast Cancer. ) In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA, and other combinations and dosage forms of estrogens and progestins. Progestins with estrogens should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman. WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT PROGESTERONE CAPSULES (A Progesterone Hormone)? Progesterone with estrogens should not be used to prevent heart disease, heart attacks, strokes, or dementia. Using progestins with estrogens may increase your chance of getting heart attacks, strokes, breast cancer, and blood clots. Using progestins with estrogens may increase your chance of getting dementia, based on a study of women age 65 and older. You and your healthcare provider should talk regularly about whether you still need treatment with progesterone capsules.

Common side effects

• Nausea
• Fatigue
• Vaginal mycosis
• Nasopharyngitis
• Upper respiratory tract infection
• Headache
• Dizziness
• Breast tenderness
• Abdominal distension
• Acne
• Dysmenorrhea
• Mood swing

Serious adverse events

• Endometrial carcinoma
• Hepatic failure
• Hepatic necrosis
• Spontaneous abortion
• Intra-uterine death
• Circulatory collapse
• Loss of consciousness
• Anaphylactic reaction
• Convulsion
• Suicidal ideation

Key clinical trials

• Clinical Outcomes of Letrozole-induced Endometrial Preparation Regimens Versus Conventional Endometrial Preparation Regimens Including Natural Cycle, Hormone Replacement Regimens in FET, a Randomized (NA)
• Comparison of Oral Dydrogesterone Versus Micronized Vaginal Progesterone for Luteal Phase Support in Frozen-thawed Embryo Transfer Cycles: a Randomized Controlled Trial (Phase 4)
• The Effectiveness of Cervical Pessary Compared to Cervical Cerclage With or Without Vaginal Progesterone for the Prevention of Preterm Birth in Women With a Twin Pregnancy and a Short Cervix: a Two-by (NA)
• A Multicenter, Open-label, Phase 2 Basket Study of MK-5684 in Participants With Selected Solid Tumors (OMAHA-015) (Phase 2)
• Optimization of Management Tactics for Women With Premature Ovarian Insufficiency, Taking Into Account Their Clinical and Hormonal Profile (Phase 1)
• The Influence of Hormone Replacement Therapy on the Cerebral Serotonin-1A Receptor Distribution and Mood in Postmenopausal Women (Phase 4)
• Adjunctive Vaginal Progesterone (Micronized Progesterone Effervescent Vaginal Tablet) in Management of Preterm Labor: A Randomized Controlled Trial (Phase 4)
• Cyclic Variation in Micronutrient Concentrations and Plasma Volume in Reproductive-Age Women (N/A)

Patents

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Endometrin CI brief — competitive landscape report
• Endometrin updates RSS · CI watch RSS
• Ferring portfolio CI