FE | Risk Minimisation Patient
Product information
Title
Qlaira® – A COC that provides high efficacy with additional benefits, including a simple regimen with no intake break1-3
- Qlaira® is the first COC to deliver estradiol and the only estradiol-releasing COC with robust data from a large real-world study2,4,5
Qlaira®, with its unique formulation:
- Qlaira® has a simple 28-day regimen (26 active pills/2 placebo pills) with no intake break, which can lead to high efficacy.1-3
To assist patients, the missed pill rules are printed directly on to the Qlaira® wallet.
- Missed pill rules for Qlaira®5
COC – combined oral contraceptive
- Ahrendt HJ, Makalová D, Parke S et al. Contraception 2009;80(5):436–444. Return to content
- Fruzzetti F, Trémollieres F and Bitzer J. Gynecol Endocrinol 2012;28(5):400–408. Return to content
- Zeun S, Lu M, Uddin A et al. Contraception 2009;14(3):221–232 Return to content
- Qlaira®. Summary of Product Characteristics. Return to content
- Dinger J, Do Minh T, Heinemann K et al. Contraception 2016;94:328–339. Return to content
- Klipping C and Marr J. Contraception 2005;71:409–416. Return to content
- Wiegratz I et al. Contraception 2004;70:97–106. Return to content
Title
Qlaira® has proven high efficacy in real life
Qlaira® demonstrated a low contraceptive failure rate:*1
Adapted from Barnett C et al. 20171
Lower contraceptive failure rates were also observed in young women (aged <25 years) compared with LNG-containing COCs2
Adjusted hazard ratios comparing the contraceptive failure rate of Qlaira®
with other COCs and LNG-COCs stratified by age groups.
Age group | HRadj (95% CI) comparing Qlaira® | HRadj (95% CI) comparing Qlaira® |
|---|---|---|
≤25 | 0.6 (0.4–1.1) | 0.4 (0.2–0.8) |
>25-≤35 | 1.0 (0.5–1.8) | 0.8 (0.4–1.8) |
>35 | 0.1 (0.0–0.6) | 0.1 (0.0–0.6) |
Adapted from Barnett C et al. 20192
* Results from the European cohort of the INAS-SCORE study. The European cohort consisted of 30,098 women with 9,120 (30.3%) being first-time users at study entry.
†Adjusted for age, parity, user status, smoking.
COC – combined oral contraceptive; INAS – International Active Surveillance Study - Safety of Contraceptives: Role of Estrogens; LNG – levonorgestrel; oCOCs – other combined oral contraceptives
- Barnett C, Hagemann C, Dinger J et al. Eur J Contracept Reprod Health Care 2017;22(1):17–23. Return to content
- Barnett C, Dinger J, Minh TD et al. Eur J Contracept &Reprod Health Care 2019;24(4):247–250. Return to content
Title
Qlaira®: High efficacy contraception without the physical and emotional compromises associated with hormone withdrawal-associated symptoms
Up to 70% of COC users suffer from HWAS during the conventional 7-day HFI.1
Qlaira®, with its 26/2 regimen (26 active pills/2 placebo pills), delivers and maintains stable levels of estradiol throughout the cycle including the HFI.2
Mean serum estradiol concentration with Qlaira®2
Qlaira® significantly reduces HWAS compared to 21/7 regimen COCs, a benefit beyond contraception3
Change from baseline to cycle 6 in headache and pelvic pain3
Adapted from Macìas G et al. 20133
COC – combined oral contraceptive; DNG – dienogest;E2V – estradiol valerate; EE – ethinyl estradiol; HFI – hormone-free interval; HWAS – hormone withdrawal-associated symptoms; VAS – visual analog scale
- Sulak PJ, Scow RD, Preece C et al. Obstet Gynaecol 2000;95:261–266. Return to content
- Fruzzetti F, Trémollieres F and Bitzer J. Gynecol Endocrinol 2012;28(5):400–408. Return to content
- Macìas G, Merki-Feld GS, Parke S et al. J Obstet Gynaecol 2013;33:591–596. Return to content
Title
Qlaira® rapidly reduces menstrual blood loss in women with heavy bleeding1
- Heavy menstrual bleeding has a negative impact on women’s quality of life:2
- 1/3 of women would switch their contraception if it reduced menstrual flow4
Qlaira®: the only COC indicated for HMB*5
An 88% reduction in MBL was seen after 6 months of treatment with Qlaira.®1
NICE defines HMB as “excessive blood loss which interferes with the woman’s physical, emotional and social quality of life.”6
*Qlaira® is the first and only COC with an indication in HMB without organic pathology in many countries worldwide.5
COC – combined oral contraceptive; HMB – heavy menstrual bleeding; MBL – menstrual blood loss
- Fraser IS, Parke S, Mellinger U et al. Eur J Contracept Reprod Health Care 2011;16:258–269. Return to content
- Bitzer J,Serrani M and Lahav A . Open Access J Contraception 2013;4:21–28. Return to content
- Jensen JT, Bitzer J, Nappi RE et al. Eur J Contracept Reprod Health Care 2020;25(2):98–105 Return to content
- Mansour D. Int J Womens Health 2014;6:367–375. Return to content
- Qlaira® Summary of Product Characteristics. Return to content
- NICE NG88, March 2020. Return to content
Title
Qlaira® has a positive effect on painful cycles and provides a considerable relief of dysmenorrheic pain1
40–50% of young women suffer from primary dysmenorrhea, a painful condition that can lead to work or school absenteeism2
- Qlaira® decreased the number of days with dysmenorrheic pain compared with baseline to a similar extent as EE/LNG1
- In addition, fewer tablets of ibuprofen were consumed due to pain1
Qlaira® decreased the number of days with with dysmenorrheic pain1
EE/LNG – ethinyl estradiol/levonorgestrel
- Petraglia F, Parke S, Serraniet M et al. Int J Gynaecol Obstet 2014;125:270–274. Return to content
- Dawood MY. Obstet Gynecol. 2006;108:428–441. Return to content
Title
Qlaira® provides high contraceptive efficacy with additional benefits, including reduced female sexual dysfunction1
Women might find talking to their doctor about sex embarrassing, and most aren’t aware their pill could be impacting their sexual function.2
Left untreated, sexual problems can negatively influence:3
Interpersonal relationships
Self-esteem
Quality of life
Qlaira® can help improve sexual desire and arousal in those experiencing sexual dysfunction due to their COC.1
Qlaira® provides:
- vs EE/LNG-containing COCs Return to content
Qlaira® improves desire and arousal, leading to significantly lessened personal distress1
COC – combined oral contraceptive; DHEA-S – dehydroepiandrosterone sulfate; EE – ethinyl estradiol; EE/LNG – ethinyl estradiol/levonorgestrel; SHBG – sex hormone binding globulin
- Davis SR, Bitzer J, Giraldi A et al. J Sex Med 2013;10:3069–3079. Return to content
- de Castro Coelho F and Barros C. Int J ReprodMed 2019:9701384. Return to content
- Lee J-J, Tan TC and Ang SB. Singapore Med J 2017; 58(6):285–288. Return to content
- Junge W, Mellinger U, Parke S et al. Clin Drug Investig 2011;31(8):573–584. Return to content
Title
Qlaira® has robust data that’s confirmed in real life1-3
Real-world evidence provides additional confidence that Qlaira®:
- Has a simple regimen that women are able to follow correctly1
- Has a positive safety profile2
- Provides high satisfaction after switch from EE-containing COC3
Qlaira® users reported high levels of satisfaction following a switch from COCs containing EE*3
- 80% of 18–25-year-olds were satisfied or very satisfied3
- 76% of women reported ‘better’ or ‘much better’ physical well-being3
- 72% of women reported ‘better’ or ‘much better’ emotional well-being3
- Qlaira® users also experienced low rates of discontinuation with only 19.8% of women discontinuing in a 12-month study3
Results from >3,000 patients in routine clinical practice over 1 year3
COC – combined oral contraceptive; EE – ethinyl estradiol
- Barnett C, Hagemann C, Dinger J et al. Eur J Contracept Reprod Health Care 2017;22(1):17–23. Return to content
- Dinger J, Do Minh T, Heinemann K et al. Contraception 2016;94:328–339. Return to content
- Briggs P, Serrani M, Vogtländer K et al. Int J Womens Health 2016;8:477–487. Return to content
Title
Qlaira®’s positive safety profile has been confirmed in real life1
Qlaira® showed a lower risk of confirmed VTE compared to other COCs, including LNG-containing COCs.*1
The results for Qlaira® compared to LNG-containing COCs alone did not reach statistical significance, because the study was not powered for this comparison.2
Qlaira®’s risk of confirmed VTE compared with other COCs*1
BMI – body mass index; COC – combined oral contraceptive; INAS – International Active Surveillance Study - Safety of Contraceptives: Role of Estrogens; LNG – levonorgestrel; oCOCs – other combined oral contraceptives
- Dinger J, Do Minh T, Heinemann K et al. Contraception 2016;94:328-339. Return to content
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