CLIMARA PRO (estradiol)
Climara Pro is a combination hormone therapy used for women with a uterus to manage moderate to severe hot flashes and night sweats associated with menopause. It also helps patients at significant risk for postmenopausal osteoporosis by helping to prevent bone loss. This medication is typically prescribed when hormonal support is needed to address the physical symptoms of menopause or to protect bone health in high-risk individuals.
How CLIMARA PRO Works
The medication works by binding to nuclear receptors in various tissues to replace estradiol, the primary estrogen that naturally declines after menopause. This process helps lower elevated levels of pituitary hormones, while the included progestin works to counteract the proliferative effects that estrogen has on the lining of the uterus.
Details
- Status
- Prescription
- First Approved
- 2003-11-21
- Routes
- TRANSDERMAL
- Dosage Forms
- SYSTEM, FILM, EXTENDED RELEASE
CLIMARA PRO Approval History
What CLIMARA PRO Treats
2 indicationsCLIMARA PRO is approved for 2 conditions since its original approval in 2003. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Vasomotor Symptoms
- Osteoporosis
CLIMARA PRO Boxed Warning
CARDIOVASCULAR DISORDERS, PROBABLE DEMENTIA, BREAST CANCER, and ENDOMETRIAL CANCER Estrogen Plus Progestin Therapy Cardiovascular Disorders and Probable Dementia The Women's Health Initiative (WHI) estrogen plus progestin substudy reported an increased risk of deep vein thrombosis (DVT), pulmonary embolism (PE), stroke and myocardial infarction (MI) 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 med...
WARNING: CARDIOVASCULAR DISORDERS, PROBABLE DEMENTIA, BREAST CANCER, and ENDOMETRIAL CANCER Estrogen Plus Progestin Therapy Cardiovascular Disorders and Probable Dementia The Women's Health Initiative (WHI) estrogen plus progestin substudy reported an increased risk of deep vein thrombosis (DVT), pulmonary embolism (PE), stroke and myocardial infarction (MI) 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 Warnings and Precautions (5.1) , and Clinical Studies (14.5) ]. The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study of WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age and 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 Warnings and Precautions (5.3) , Use in Specific Populations (8.5) , and Clinical Studies (14.6) ]. Do not use estrogen plus progestogen therapy for the prevention of cardiovascular disease or dementia [see Warnings and Precautions (5.1 , 5.3) , and Clinical Studies (14.5 , 14.6) ] . Breast Cancer The WHI estrogen plus progestin substudy demonstrated an increased risk of invasive breast cancer [see Warnings and Precautions (5.2) , and Clinical Studies (14.5) ] . Only daily oral 0.625 mg CE and MPA were studied in the estrogen plus progestin substudy of the WHI. Therefore, the relevance of the WHI findings regarding adverse cardiovascular events, dementia and breast cancer to lower CE plus other MPA doses, other routes of administration, or other estrogen plus progestogen products is not known. Without such data, it is not possible to definitively exclude these risks or determine the extent of these risks for other products. Discuss with your patient the benefits and risks of estr
CLIMARA PRO 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.
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.
CLIMARA PRO FDA Label Details
Indications & Usage
FDA Label (PDF)CLIMARA PRO is indicated for the treatment of Vasomotor Symptoms; Osteoporosis.
WARNING: CARDIOVASCULAR DISORDERS, PROBABLE DEMENTIA, BREAST CANCER, and ENDOMETRIAL CANCER Estrogen Plus Progestin Therapy Cardiovascular Disorders and Probable Dementia The Women's Health Initiative (WHI) estrogen plus progestin substudy reported an increased risk of deep vein thrombosis (DVT), pu...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.