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Qlaira®

(Estradiol valerate/dienogest)

A combined oral contraceptive (COC) licensed for the treatment of heavy menstrural bleeding in women without organic pathology.

Qlaira® is a combined oral contraceptive (COC) pill licensed for the treatment of heavy menstrual bleeding in women without organic pathology who desire oral contraception.^*

Qlaira® therapeutic indications

Oral contraception.
Treatment of heavy menstrual bleeding in women without organic pathology who desire oral contraception.

The decision to prescribe Qlaira should take into consideration the individual woman's current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Qlaira compares with other combined hormonal contraceptives (CHCs) (see sections 4.3 and 4.4 of the SmPC for further information).

^{* The dose schedule for this indication is the same as that for normal contraceptive use.}

Qlaira® Summary of Product Characteristics (SmPC):

Summary of Product Characteristics

After switching to Qlaira® or POP from an EE-containing regimen, Qlaira® resulted in higher continuation rates and patient satisfaction when compared to POP (n=3152).

High rates of satisfaction with Qlaira® vs POP in both age groups 3-5 months after switching to Qlaira® or POP

^{POP=progestogen-only pill.}

More information on Study design and participants

Study design and participants:

A Phase IV, prospective, multicenter, noninterventional, observational study in 3,152 women (aged 18–50 years) switching from an EE-containing OC pill to the E2V/DNG pill or a POP. The study was conducted at 375 investigational sites in eleven countries: the Czech Republic, France, Germany, Greece, Hungary, Israel, Italy, the Russian Federation, Slovakia, Sweden, and the UK.

For inclusion, women must have been using EE-containing OCs for ≥3 months prior to enrollment and must have decided to switch either to the E2V/DNG pill or to a POP, depending on individual choice. Exclusion criteria were in accordance with the contraindications, precautions, and warnings for women receiving the E2V/DNG pill or chosen POP based on the approved product labeling in each country. Women who were breastfeeding were also excluded.

The E2V/DNG pill was administered via a dynamic dosing regimen (E2V 3 mg on days 1 and 2, E2V 2 mg/DNG 2 mg on days 3–7, E2V 2 mg/DNG 3 mg on days 8–24, E2V 1 mg on days 25–26, and placebo on days 27–28). The chosen POP was administered according to the relevant prescribing information. As this is a noninterventional study, the duration of treatment was at the discretion of the physician. Women were followed for 1 year.

Adapted from: Briggs P et al. Int J Womens Health 2016;8:477–487.

High rates of satisfaction with Qlaira® vs POP in both age groups 3–5 months after switching to Qlaira® or POP
High rates of satisfaction were also seen in younger women

Qlaira® (Estradiol valerate/dienogest) | Estradiol Valerate

Learn more about Qlaira® Estradiol Valerate.

Qlaira® Prescribing Information

PP-QLA-IE-0002-1, January 2026

Qlaira® (Estradiol valerate/dienogest) | Dosing

Discover dosing of Qlaira®

Qlaira® Prescribing Information

PP-QLA-IE-0004-1, January 2026

Qlaira® (Estradiol valerate/dienogest) | FAQs

Discover frequently asked questions about Qlaira®.

Qlaira® Prescribing Information

PP-QLA-IE-0003-1, January 2026

PP-QLA-IE-0001-1 | January 2026

References

1
Ahrendt HJ, Makalová D, Parke S, et al. Contraception, 2009;80(5):436–444
2
Junge W, Mellinger U, Parke S, et al. Clin Drug Investig, 2011;31(8):573-584.
3
Klipping C, Duijkers I, Parke S, et al. Drugs R D 2011;11(2):159-170.
4
Qlaira® (Estradiol valerate/dienogest) Summary of Product Characteristics.
5
Briggs P et al. Int J Womens Health 2016;8:477–487.