MENOSTAR (estradiol)
Menostar is an estrogen medication used to help prevent osteoporosis in women who have gone through menopause. It is specifically used for patients at significant risk of bone loss, typically after a healthcare provider has first considered non-estrogen treatment options. This therapy helps maintain bone health by providing a supplemental source of estradiol, the primary and most potent estrogen found in the human body.
How MENOSTAR Works
This medication works by binding to nuclear receptors within estrogen-responsive tissues to mimic the effects of naturally occurring estradiol. By activating these receptors, the drug helps regulate the body's endocrine balance and reduces the elevated levels of pituitary hormones, such as follicle stimulating hormone, that are commonly seen in postmenopausal women.
Details
- Status
- Prescription
- First Approved
- 1994-12-22
- Routes
- TRANSDERMAL
- Dosage Forms
- FILM, EXTENDED RELEASE, SYSTEM
MENOSTAR Approval History
What MENOSTAR Treats
1 indicationsMENOSTAR is approved for 1 conditions since its original approval in 1994. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Postmenopausal Osteoporosis
MENOSTAR Boxed Warning
ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, PROBABLE DEMENTIA and BREAST CANCER 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 progestogen to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Perform adequate diagnostic measures, including directed or random endometrial sampling when indicated to rule out malign...
WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, PROBABLE DEMENTIA and BREAST CANCER 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 progestogen to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Perform adequate diagnostic measures, including directed or random endometrial sampling when indicated 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 The Women's Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg]-alone, relative to placebo [see Warnings and Precautions (5.1) , and Clinical Studies (14.2) ] . The WHI Memory Study (WHIMS) estrogen-alone ancillary study of WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age and older during 5.2 years of treatment with daily CE (0.625 mg)-alone, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women [see Warnings and Precautions (5.3) , Use in Specific Populations (8.5) , and Clinical Studies (14.3) ] . Do not use estrogen-alone therapy for the prevention of cardiovascular disease or dementia [see Warnings and Precautions (5.1 , 5.3) , and Clinical Studies (14.2 , 14.3) ] . Only daily oral 0.625 mg CE was studied in the estrogen-alone substudy of the WHI. Therefore, the relevance of the WHI findings regarding adverse cardiovascular events and dementia to lower CE doses, other routes of administration, or other estrogen-alone products is not known. Without such data, it is not possible to definitively exclud
MENOSTAR 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.
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Clinical Trial Registry
33 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05716516 ESTHER | STUDY02001740 NCI-2023-05453 | Ph 2 | recruiting | STUDY02001740;22SCH740: Estradiol For ER+ Advanced Breast Cancer (ESTHER) |
| NCT06005610 GETITRIgHT results posted | A5403 38806 | Ph 2 | terminated | Estradiol Therapy In Transgender Women to Research Interactions With HIV Therapy |
| NCT05457972 | STUDY20220578 | Ph 4 | recruiting | Postpartum Vaginal Estrogen for Breastfeeding Patients |
| NCT04192266 results posted | HSC-MS-23-0497 R33MH111907 | Ph 3 | completed | Estrogen and Fear in PTSD |
| NCT03689543 results posted | 180144 18-M-0144 | Ph 2 | completed | Estrogen Receptor Beta and Mood |
| NCT06253702 | 2023-0548 1R01HL150361-01, EDUC/KINESIOLOGY | Ph 4 | completed | Brain Blood Flow Responses to Stress: Sex Differences |
| NCT02238808 PRESTO | EER001 | Ph 2 | active not recruiting | A Study to See Whether Estrogen Can Slow the Growth of Some ER Positive Breast Cancers |
| NCT05617820 | 71836003 | Ph 3 | completed | Study Comparing Estradiol Vaginal Inserts 4mcg To IMVEXXY ® (Estradiol Vaginal Inerts 4 mcg) In The Treatment Of Dyspareunia in Women With Vulvur and Vaginal Atrophy |
| NCT04225221 results posted | 19-2343 R21MH121726 | Ph 2 | completed | Neurobiology of Bulimia Nervosa |
| NCT04933240 | HM20021901 | Ph 4 | withdrawn | Tamoxifen Versus Estradiol for Unscheduled Bleeding in Etonogestrel Implant Users, a Randomized Pilot Trial |
| NCT01923298 results posted | 13-0477-04 EString | Ph 2 | completed | Estradiol Levels in Patients Treated With Estring |
| NCT03493126 results posted | 2018H0006 | Ph 4 | completed | Vaginal Estrogen on Postpartum Atrophy, Perineal Pain, and Sexual Function |
| NCT02995694 results posted | 71462901 | Ph 3 | completed | A Study Comparing Estradiol Vaginal Cream to Estrace® Cream in Females With Atrophic Vaginitis |
| NCT01441635 results posted | M12-663 | Ph 2 | completed | Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids |
| NCT01895881 EPPA | EPPA - 12101906 | Ph 2 | withdrawn | Estrogen Therapy as Prevention in the Progression of Aneurysm (EPPA) Trial |
| NCT00997893 RISE results posted | 2009-0052 5R01MH083782-05 | Ph 2 | completed | Research Investigation of Soy and Estrogen |
| NCT03848234 | EST-S-01 | Ph 3 | completed | Estradiol Patch as add-on to Antipsychotics in Patients With Schizophrenia, Schizoaffective or Schizophreniform Disorder |
| NCT02455453 results posted | 201411005 5R01CA195450-03 | Ph 2 | completed | Assessment of Functional Status of Estrogen Receptors in Breast Cancer by Positron Emission Tomography |
| NCT01083641 results posted | CO09711 H-2009-0172, NCI-2011-00618 | Ph 2 | terminated | Estrogen for Triple Negative Breast Cancer |
| NCT02255175 PEERS results posted | 13-3572 K12HD001441-15, K23MH105569-01A1 | Ph 4 | completed | Perimenopausal Effects of Estradiol on Reward Responsiveness |
| NCT01942668 REPLENISH results posted | TXC12-05 REPLENISH Trial | Ph 3 | completed | A Safety and Efficacy Study of the Combination Estradiol and Progesterone to Treat Vasomotor Symptoms |
| NCT03479879 | AS1731 | Ph 2, Ph 3 | completed | Estradiol Pretreatment With Misoprostol in Second Trimester Miscarriage |
| NCT01753102 | CLR_10_19 CTRI/2012/09/002983 | Ph 3 | terminated | Efficacy and Safety Of Spil's Estradiol Vaginal Tablet |
| NCT02792153 | IRB00030009 | Ph 1 | withdrawn | Estradiol and Fear Extinction in Anorexia Nervosa (AN) |
| NCT01126801 results posted | 2009p001776 | Ph 2 | terminated | Effects of Estrogen and Hot Flashes on Mood in Postmenopausal Women |
| NCT01308814 PERT results posted | 10-0542 R01MH087619 | Ph 2, Ph 3 | completed | Perimenopausal Estrogen Replacement Therapy Study |
| NCT02253173 REJOICE results posted | TXV14-01 | Ph 3 | completed | Estradiol Vaginal Softgel Capsules in Treating Symptoms of Vulvar and Vaginal Atrophy in Postmenopausal Women |
| NCT02485821 | MS39825273 | Ph 2, Ph 3 | completed | Vaginal Estradiol Pretreatment in Labour Induction With Misoprostol |
| NCT02449902 results posted | TXV13-01 | Ph 2 | completed | TXV13-01 Estradiol Vaginal Softgel Capsules in Treating Postmenopausal Women With Symptoms of Vulvar and Vaginal Atrophy |
| NCT02316249 | NSHS-P001 | Ph 2 | withdrawn | Vaginal Creams to Reduce Vaginal Erosion in Pessary Users |
| NCT01310647 FOLLPRIM | 2009-018009-26 2009-018009-26 | Ph 2 | completed | Antral Follicle Priming Prior to ICSI (Intracytoplasmic Sperm Injection) in Previously Diagnosed Low Responders |
| NCT01065220 | AP13214ONB | Ph 4 | completed | Sex Steroids and the Serotonin Transporter |
| NCT00740194 | 2007/279 | Ph 1, Ph 2 | completed | Reciprocal Influence of Sex Steroid Environment and Adipocyte Function in Men |
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.
MENOSTAR FDA Label Details
Indications & Usage
FDA Label (PDF)MENOSTAR is indicated for the treatment of Postmenopausal Osteoporosis.
WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, PROBABLE DEMENTIA and BREAST CANCER 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 progestogen to estrogen therapy has been shown to redu...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.