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Progesterone (Progesterone plus HCG)
At a glance
| Generic name | Progesterone plus HCG |
|---|---|
| Also known as | Utrogestan |
| Sponsor | Dunamenti REK Istenhegyi IVF Center |
| Drug class | Progesterone [EPC] |
| Target | progesterone receptor, luteinizing hormone/choriogonadotropin receptor |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 1978 |
Approved indications
- Abortion
- Induction of labor
- Menstrual disorders
- Miscarriage
- Pregnancy maintenance
- Pregnancy termination
- Therapeutic abortion
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
- Headache
- Breast Tenderness
- Joint Pain
- Depression
- Dizziness
- Abdominal Bloating
- Hot Flashes
- Urinary Problems
- Abdominal Pain
- Vaginal Discharge
- Nausea / Vomiting
- Worry
Drug interactions
- Warfarin
- Rifampicin
- Phenytoin
- Carbamazepine
- Hormonal contraceptives
- HCG (human chorionic gonadotropin)
- Estrogen
- Tamoxifen
- Aromatase inhibitors
Key clinical trials
- MIcronized PROgesterone in Frozen Embryo Transfer Cycles (PHASE3)
- PErsonalized Addition of Recombinant LH in Ovarian Stimulation (PHASE4)
- INTEnsity of ovariaN Stimulation and Embryo Quality (PHASE4)
- A Study to Compare the Efficacy and Safety of Follitropin Alfa/Lutropin Alfa Versus hMG in Japanese Participants With LH and FSH Deficiency Undergoing ART (HINATA) (PHASE3)
- Impact Of FET Preparation Protocol On Endometrial Peristalsis: A Prospective Cohort Study
- Assessment of the Feasibility of Frozen Embryo Transfers in a Natural Cycle Among Obese Compared to Non-Obese Patients
- Assessing the Convenience of Natural Proliferative Phase Frozen Embryo Transfer
- FET-LET-2x2: Clinical Pregnancy Rates After Frozen Embryo Transfer in Natural and Modified Natural Cycles (NA)
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |