Data updated: May 26, 2026
DITATE-DS (estradiol valerate)
Oncology
Approved 1982-06-29
Details
- Status
- Discontinued
- First Approved
- 1982-06-29
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
DITATE-DS Approval History
1983
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Original
New Indication
New Form
Label Update
8 FDA actions from 1982 to 1986
Nov 1986 SUPPL
Mfg · Manufacturing (CMC)
Oct 1986 SUPPL
Mfg · Manufacturing (CMC)
Sep 1984 SUPPL
Mfg · Manufacturing (CMC)
Jan 1983 SUPPL
Mfg
Jun 1982 SUPPL
Mfg
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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| NCT04002635 LEFT | 2019LEFT001 | Ph 4 | withdrawn | Letrozole for Frozen Embryo Transfer (FET) in Patients With Polycystic Ovary Syndrome (PCOS) |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 |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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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.
DITATE-DS FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.