PREMPHASE 14/14 (estrogens, conjugated)
Premphase 14/14 is a fixed-dose combination hormone therapy (conjugated estrogens and medroxyprogesterone acetate) indicated for women with an intact uterus to treat moderate to severe vasomotor symptoms and vulvar/vaginal atrophy associated with menopause.
How PREMPHASE 14/14 Works
This drug works by binding to nuclear receptors in estrogen-responsive tissues to mimic the effects of naturally occurring hormones. Once bound, it modulates the secretion of certain hormones from the pituitary gland through a negative feedback mechanism. This action reduces the elevated levels of luteinizing hormone and follicle-stimulating hormone typically seen in postmenopausal women.
Details
- Status
- Prescription
- First Approved
- 1995-11-17
- Routes
- ORAL-28
- Dosage Forms
- TABLET
PREMPHASE 14/14 Approval History
What PREMPHASE 14/14 Treats
6 indicationsPREMPHASE 14/14 is approved for 6 conditions since its original approval in 1995. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Vasomotor Symptoms
- Vulvar and Vaginal Atrophy
- Hypoestrogenism
- Breast Cancer
- Prostate Cancer
- Osteoporosis
PREMPHASE 14/14 Boxed Warning
ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA See full prescribing information for complete boxed warning. Estrogen-Alone Therapy • There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens ( 5.2 ) • Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia ( 5.1 , 5.3 ) • Women's Healt...
WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA See full prescribing information for complete boxed warning. Estrogen-Alone Therapy • There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens ( 5.2 ) • Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia ( 5.1 , 5.3 ) • Women's Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) ( 5.1 ) • The WHI Memory Study (WHIMS) estrogen-alone ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older ( 5.3 ) Estrogen Plus Progestin Therapy • Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia ( 5.1 , 5.3 ) • The WHI estrogen plus progestin substudy reported increased risks of stroke, DVT, pulmonary embolism (PE), and myocardial infarction (MI) ( 5.1 ) • The WHI estrogen plus progestin substudy reported increased risks of invasive breast cancer ( 5.2 ) • The WHIMS estrogen plus progestin ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older ( 5.3 ) Estrogen-Alone Therapy Endometrial Cancer There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding [see Warnings and Precautions (5.2) ]. Cardiovascular Disorders and Probable Dementia Estrogen-alone t
PREMPHASE 14/14 Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in PREMPHASE 14/14's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications PREMPHASE 14/14 treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to PREMPHASE 14/14
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
PREMPHASE 14/14 FDA Label Details
Indications & Usage
FDA Label (PDF)PREMPHASE 14/14 is indicated for the treatment of Vasomotor Symptoms; Vulvar and Vaginal Atrophy; Hypoestrogenism; Breast Cancer; Prostate Cancer; Osteoporosis.
WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA See full prescribing information for complete boxed warning. Estrogen-Alone Therapy • There is an increased risk of en...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.