ESTRADIOL VALERATE
ESTRADIOL VALERATE is indicated for the treatment of Vasomotor Symptoms; Vulvar and Vaginal Atrophy; Hypoestrogenism; Prostate Cancer.
Details
- Status
- Prescription
- First Approved
- 1979-02-28
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
ESTRADIOL VALERATE Approval History
What ESTRADIOL VALERATE Treats
4 indicationsESTRADIOL VALERATE is approved for 4 conditions since its original approval in 1979. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Vasomotor Symptoms
- Vulvar and Vaginal Atrophy
- Hypoestrogenism
- Prostate Cancer
ESTRADIOL VALERATE Boxed Warning
ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding. There is no evidence that the use of "natural" estrogens results in a different endometrial risk profile than synthetic estrogens at equivalent estrogen doses. [see WARNINGS, Mal...
ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding. There is no evidence that the use of "natural" estrogens results in a different endometrial risk profile than synthetic estrogens at equivalent estrogen doses. [see WARNINGS, Malignant neoplasms, Endometrial cancer ]. CARDIOVASCULAR AND OTHER RISKS Estrogens and progestins should not be used for the prevention of cardiovascular disease [see WARNINGS, Cardiovascular disorder s] . The Women's Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5 years of treatment with oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) relative to placebo [see CLINICAL PHARMACOLOGY, Clinical Studies ]. The Women's Health Initiative Memory Study (WHIMS), a substudy of WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with oral conjugated estrogens plus medroxyprogesterone acetate relative to placebo. It is unknown whether this finding applies to younger postmenopausal women or to women taking estrogen alone therapy [see CLINICAL PHARMACOLOGY, Clinical Studies ]. Other doses of oral conjugated estrogens with medroxyprogesterone acetate, and other combinations and dosage forms of estrogens and progestins were not studied in the WHI clinical trials and, in the absence of comparable data, these risks should be assumed to be similar. Because of these risks, estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with
ESTRADIOL VALERATE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
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 ESTRADIOL VALERATE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ESTRADIOL VALERATE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to ESTRADIOL VALERATE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
11 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03642665 NAFT | S61372 | Ph 4 | completed | Natural Versus Artificial Cycle for Frozen-Thawed Embryo Transfer |
| NCT03976544 | HRT_NC-FET 2018-003156-20 | Ph 4 | terminated | Natural Cycle Versus Hormone Replacement Therapy Cycle for a Frozen-thawed Embryo Transfer in PGT Patients |
| NCT04507022 | RFC041120190008 | Ph 4 | completed | The Outcome of Two Protocols Used to Prepare Endometrium for Frozen Embryo Transfer |
| NCT04002635 LEFT | 2019LEFT001 | Ph 4 | withdrawn | Letrozole for Frozen Embryo Transfer (FET) in Patients With Polycystic Ovary Syndrome (PCOS) |
| NCT00816556 results posted | 07-008730 UL1TR000135 | Ph 3 | terminated | A Trial to Evaluate the Efficacy of Low Dose Vaginal Estrogens in the Treatment of Atrophic Vaginitis |
| NCT02352597 PCOS | 222 | Ph 4 | completed | Phytoestrogens as an Alternative to Estradiol in Ovulation Induction in PCOS |
| NCT02845388 | Ainshams2015Omar | Ph 2 | completed | Sildenafil Citrate in Frozen Embryo Transfer |
| NCT01501448 | IVIMAD-GV-OCPE-2011 | Ph 4 | completed | Oral Estradiol Valerate Versus Oral Contraceptive Pill in Invitro Fertilization Patients |
| NCT01419353 | Antagonist_prog | Ph 4 | completed | Programming by Estrogen Treatment in Gonadotropin Releasing Hormone Antagonist Protocol |
| NCT01218386 | 2010-019924-30 | Ph 4 | completed | Pretreatment With Estradiol Valerate |
| NCT00755963 | PM-20070724 EudraCT: 2007-005685-12, EC 593/2007 | Ph 4 | completed | Effects of Hormone Replacement Therapy on the Serotonergic System and Mood in Postmenopausal Women |
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.
ESTRADIOL VALERATE FDA Label Details
Indications & Usage
ESTRADIOL VALERATE is indicated for the treatment of Vasomotor Symptoms; Vulvar and Vaginal Atrophy; Hypoestrogenism; Prostate Cancer.
ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnor...
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DITATE-DS
Full clinical data, patents, trials, and competitive landscape for estradiol valerate.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.