DELESTROGEN (estradiol valerate) · PH HEALTH
DELESTROGEN is FDA-approved to treat 4 conditions (same as ESTRADIOL VALERATE).
Development Insights
Details
- Status
- Discontinued
- First Approved
- 1954-07-15
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
DELESTROGEN Approval History
What DELESTROGEN Treats
4 indicationsDELESTROGEN is approved for 4 conditions since its original approval in 1954. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Vasomotor Symptoms
- Vulvar and Vaginal Atrophy
- Hypoestrogenism
- Prostate Cancer
Same approved indications as ESTRADIOL VALERATE (same active ingredient).
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| NCT04002635 LEFT | 2019LEFT001 | Ph 4 | withdrawn | Letrozole for Frozen Embryo Transfer (FET) in Patients With Polycystic Ovary Syndrome (PCOS) |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.
DELESTROGEN FDA Label Details
Indications & Usage
FDA Label (PDF)DELESTROGEN is FDA-approved to treat 4 conditions — same approved indications as ESTRADIOL VALERATE.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment