ESTRADIOL VALERATE AND DIENOGEST (dienogest)
This combination oral contraceptive (COC) contains estradiol valerate (an estrogen) and dienogest (a progestin). It is indicated for the prevention of pregnancy in females of reproductive potential and for the treatment of heavy menstrual bleeding in females without organic pathology who desire oral contraception. The efficacy of this medication has not been evaluated in patients with a body mass index (BMI) greater than 30 kg/m².
How ESTRADIOL VALERATE AND DIENOGEST Works
Estradiol valerate and dienogest prevent pregnancy primarily by suppressing ovulation through the inhibition of gonadotropin secretion (follicle-stimulating hormone and luteinizing hormone). Secondary mechanisms include thickening of the cervical mucus to impede sperm migration and alterations in the endometrium to reduce the likelihood of implantation. For heavy menstrual bleeding, the combination promotes endometrial stability and reduces excessive proliferation.
Development Insights
Details
- Status
- Prescription
- First Approved
- N/A
- Routes
- ORAL
- Dosage Forms
- TABLET
ESTRADIOL VALERATE AND DIENOGEST Approval History
What ESTRADIOL VALERATE AND DIENOGEST Treats
1 indicationsESTRADIOL VALERATE AND DIENOGEST is approved for 1 conditions . These indications span multiple therapeutic areas including oncology, immunology, and more.
- Heavy Menstrual Bleeding
ESTRADIOL VALERATE AND DIENOGEST Boxed Warning
CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke. [See Contraindications ( 4 ).] WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See full prescribing information...
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke. [See Contraindications ( 4 ).] WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See full prescribing information for complete boxed warning. • Women over 35 years old who smoke should not use Natazia. ( 4 ) • Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. ( 4 )
ESTRADIOL VALERATE AND DIENOGEST 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.
Drugs Similar to ESTRADIOL VALERATE AND DIENOGEST
3 of 4FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
7 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07164183 Baikal | IND-III-2024 | Ph 3 | recruiting | Clinical Study to Compare Efficacy and Safety of Indinol Forto® 200 mg Capsules and Visanne 2 mg Tablets in Treatment of Endometriosis |
| NCT06145438 ENDOSafe | 00000088 | Ph 3 | completed | Comparing the Safety and Efficacy in the Use of Hormonal Therapy on Endometriosis Patients After Conservative Surgery |
| NCT02352090 SYLVI results posted | SYLVI030785 | Ph 4 | completed | Synthetic vs Natural Estrogen in Combined Oral Contraception |
| NCT01738724 | FMRPUSP-UROGIN-002 | Ph 4 | terminated | Study of the Efficacy of Dienogest in the Treatment of Uterine Leiomyomas When Compared to Desogestrel and Goserelin |
| NCT02728245 DOROSY | SNUBH_GO_052 | Ph 2 | withdrawn | Trial Comparing Preoperative Dienogest Therapy Followed by Surgery vs. Upfront Surgery to Save Ovarian Reserve in Young Women With Ovarian Endometrioma |
| NCT02599077 | FSantafeBogota | Ph 2, Ph 3 | suspended | Impact vs. Dienogest: A Combined Oral Contraceptive in the Size of Endometriomas |
| NCT01697111 | 15457 | Ph 3 | completed | Comparative Study of BAY86-5300 With an Extended Flexible Regimen for Endometriosis |
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 AND DIENOGEST FDA Label Details
Indications & Usage
ESTRADIOL VALERATE AND DIENOGEST is indicated for the treatment of Heavy Menstrual Bleeding.
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For t...
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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