COC with natural estrogen (quadriphasic)
ATC code: G03AA16 (Dienogest and estrogen)
Estradiol valerate hydrolyzes to estradiol – a natural estrogen identical to endogenous. Dienogest is an antiandrogenic progestin. The quadriphasic Qlaira regimen mimics the natural cycle with decreasing estrogen and increasing progestin doses. Hemostasis effects are milder than with ethinylestradiol – VTE risk is intermediate (INAS-FOCUS study).
First line
Regular contraception, especially in women >35 and with sensitivity to ethinylestradiol. Per SEGO 2023, Qlaira is recommended for heavy and prolonged menstrual bleeding – -approved for this (PRO-MENS RCT 2014). 26 active + 2 placebo tablets.
First line
Heavy menstrual bleeding in women without organic pathology (fibroids, adenomyosis, polyps). PRO-MENS RCT 2014 showed 88% reduction in menstrual blood loss vs placebo. Per NG88 2018 and SEGO 2023, drug of choice in women who also need contraception. Alternative – LNG-IUS (Mirena) with up to 90% blood loss reduction.
The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.
Not recommended
Qlaira during breastfeeding. MEC 2015 category 4 first 6 weeks, then 2. Although estradiol is natural (milder than ethinylestradiol), it still reduces milk supply. Dienogest transfers to milk in small amounts (RID about 1%). Progestin-only is preferred.
Opens the checker prefilled with this drug. Pick the second one from your regimen.
Direct links to regulator labels. Open in a new tab.
Discontinue if pregnant.
Estradiol reduces milk supply, milder than ethinylestradiol. WHO MEC first 6 weeks – category 4. Dienogest RID about 1%, Hale L3.
Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.
Estradiol valerate + Dienogest is evaluated for the following indications with varying evidence strength: Contraception (evidence tier A), Heavy menstrual bleeding (evidence tier A), Contraception during breastfeeding (evidence tier D). See the full indication matrix with dosing and citations above on this page.
Common side effects of Estradiol valerate + Dienogest (≥ 1 in 100): Headache, Breast tenderness, Nausea, Acne (rare with dienogest), Amenorrhea (3-12%). See the Safety section for uncommon and serious reactions.
FDA category X. Discontinue if pregnant.
Estradiol reduces milk supply, milder than ethinylestradiol. WHO MEC first 6 weeks – category 4. Dienogest RID about 1%, Hale L3.
Estradiol valerate + Dienogest is contraindicated in: VTE; Thrombophilia; Smoking after 35; Migraine with aura; HTN. Full list in the Safety section.