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Estradiol valerate / dienogest
Estradiol valerate and dienogest work together as a hormonal contraceptive by suppressing ovulation through progestin and estrogen activity.
Estradiol valerate and dienogest work together as a hormonal contraceptive by suppressing ovulation through progestin and estrogen activity. Used for Contraception, Regulation of menstrual cycle.
At a glance
| Generic name | Estradiol valerate / dienogest |
|---|---|
| Also known as | Qlaira, ATC code G03AB08 |
| Sponsor | Helsinki University Central Hospital |
| Drug class | Oral contraceptive (combined estrogen-progestin) |
| Target | Estrogen receptor and progesterone receptor |
| Modality | Small molecule |
| Therapeutic area | Contraception / Gynecology |
| Phase | FDA-approved |
Mechanism of action
Estradiol valerate is an estrogen that provides estrogenic activity, while dienogest is a progestin that suppresses the luteinizing hormone (LH) surge necessary for ovulation. Together, they create a hormonal environment that prevents follicle development and ovulation, and also thickens cervical mucus to impede sperm penetration. This combination is used in oral contraceptive formulations.
Approved indications
- Contraception
- Regulation of menstrual cycle
Common side effects
- Nausea
- Headache
- Breast tenderness
- Breakthrough bleeding
- Mood changes
- Venous thromboembolism
Key clinical trials
- Ultra-Safe Hormonal Strategy: Transdermal Estradiol Added to Progestins for Endometriosis
- "Quick-starting" of a Quadriphasic Contraceptive Pills, 1 - 3 mg Estradiol Valerate/ 2 - 3 mg Dienogest VS 20 mcg Ethinylestradiol/75 mcg Gestodene Focusing on Ovulation Inhibition (NA)
- The Progression From Dysmenorrhoea to Chronic Pelvic Pain
- Comparing the Safety and Efficacy in the Use of Hormonal Therapy on Endometriosis Patients After Conservative Surgery (PHASE3)
- To Compare SH T00658ID Over Ortho Tri-Cyclen Lo (US/Canada) (PHASE3)
- A Study Run At Multiple Study Sites to Test Whether the SAMANTA Questionnaire That is Used to Diagnose Heavy Menstrual Bleeding (HMB), Can Also Be Used to Assess Changes of Severity of HMB in Women with HMB Who Are Treated During 12 Months with a Chronic Hormonal Treatment
- Role of Medical Treatment in Endometriosis Patients Undergoing ICSI (NA)
- Gonadotropin-releasing Hormone (GnRH) Downregulation Versus Oral Anticonception Prior to ART in Postoperative Endometriosis Patients (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Estradiol valerate / dienogest CI brief — competitive landscape report
- Estradiol valerate / dienogest updates RSS · CI watch RSS
- Helsinki University Central Hospital portfolio CI