Qlaira
Qlaira is a combined oral contraceptive pill containing estradiol valerate and dienogest.
It uses a unique dynamic dosing regimen with four different dose phases across a 28-day blister strip, including two placebo tablets.
Qlaira is the first combined oral contraceptive to use natural oestrogen (estradiol valerate) rather than synthetic ethinylestradiol.
It is also licensed for the treatment of heavy menstrual bleeding. Qlaira is a prescription-only medicine (POM) in the UK, manufactured by Bayer.
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Qlaira is a combined oral contraceptive pill containing estradiol valerate and dienogest.
It is the first combined pill to use a natural oestrogen (estradiol valerate) rather than synthetic ethinylestradiol, and it employs a unique dynamic dosing regimen across five phases within each 28-day blister strip.
Qlaira provides reliable contraception and is also licensed for the treatment of heavy menstrual bleeding in women who choose oral contraception as their method.
It is a prescription-only medicine (POM) in the United Kingdom, manufactured by Bayer.
Combined oral contraceptives remain one of the most popular reversible methods of contraception in the UK, used by millions of women.
The development of Qlaira represents a significant advance in oral contraceptive design, moving away from synthetic oestrogens towards a natural oestrogen formulation that more closely mirrors the body's own hormonal patterns.
Estradiol valerate is a prodrug that is rapidly converted to estradiol, the same oestrogen naturally produced by the ovaries.
This may offer advantages in terms of metabolic impact and tolerability for some women.
This page provides a comprehensive clinical guide to Qlaira, including how it works, its unique dosing schedule, side effects, safety warnings, and how to obtain it in the United Kingdom.
Important safety information about Qlaira
Before reading further, please note these essential safety points.
- Qlaira must not be used by women with a history of or current venous or arterial thromboembolism, migraine with aura, or severe cardiovascular risk factors.
- All combined hormonal contraceptives carry a small increased risk of blood clots (VTE). Know the symptoms: sudden leg swelling or pain, sudden breathlessness, chest pain.
- Smoking and combined pill use together significantly increase cardiovascular risk. Do not use Qlaira if you are over 35 and smoke.
- Qlaira has a complex dosing schedule. Follow the tablet order on the blister strip carefully.
- If you suspect a DVT, PE, or stroke, call 999 immediately.
Understanding combined oral contraception
Combined oral contraceptives (COCs) contain an oestrogen and a progestogen. They work primarily by suppressing ovulation through inhibition of gonadotrophin release from the pituitary gland.
The progestogen component also thickens the cervical mucus (making it hostile to sperm penetration) and thins the endometrium (reducing the likelihood of implantation).
When used correctly, COCs are more than 99% effective at preventing pregnancy. With typical use (accounting for missed pills and other human factors), effectiveness is approximately 91%.
Most combined pills available in the UK contain ethinylestradiol, a potent synthetic oestrogen.
Ethinylestradiol is highly effective at suppressing ovulation but has a greater impact on hepatic protein synthesis than natural estradiol, which may contribute to the thrombotic risk associated with COCs.
Qlaira was developed to provide effective contraception using estradiol valerate, a natural oestrogen, with the aim of achieving a more physiological hormonal profile and potentially reducing some oestrogen-related side effects.
What Qlaira contains and how it works
Qlaira uses a dynamic dosing regimen that changes the hormone content across the cycle. The 28-day strip contains five tablet types in a specific order.
Days 1 and 2 deliver estradiol valerate 3 mg alone (dark yellow tablets), providing an initial oestrogen-dominant phase.
Days 3 to 7 deliver estradiol valerate 2 mg plus dienogest 2 mg (medium red tablets), introducing the progestogen.
Days 8 to 24 deliver estradiol valerate 2 mg plus dienogest 3 mg (light yellow tablets), with the higher progestogen dose ensuring reliable ovulation suppression and endometrial stability.
Days 25 and 26 deliver estradiol valerate 1 mg alone (dark red tablets), stepping down oestrogen. Days 27 and 28 are white placebo tablets containing no hormones.
A withdrawal bleed, if it occurs, typically happens during the placebo phase or the low-oestrogen phase.
Estradiol valerate is an ester of estradiol that is rapidly hydrolysed in the gut wall and liver to release estradiol, the principal and most biologically active oestrogen.
Unlike ethinylestradiol, estradiol is metabolised via natural pathways and has a shorter half-life.
The dynamic dosing compensates for estradiol's lower potency compared with ethinylestradiol by adjusting doses across the cycle.
Dienogest is a fourth-generation progestogen with unique pharmacological properties.
It combines structural features of 19-nortestosterone derivatives (providing strong progestogenic activity and reliable ovulation suppression) with features of progesterone derivatives (providing moderate anti-androgenic activity without androgenic, oestrogenic, or glucocorticoid effects).
This anti-androgenic property may benefit women with acne or other androgen-sensitive conditions, although Qlaira is not specifically licensed for acne treatment.
Clinical evidence and UK prescribing guidance
Qlaira was approved based on phase III clinical trials involving more than 3,700 women.
These trials demonstrated a Pearl Index (the rate of unintended pregnancies per 100 woman-years of use) of approximately 0.34 to 0.79, indicating high contraceptive efficacy.
The trials also showed that Qlaira produced lighter and shorter withdrawal bleeds compared with conventional COCs.
A significant proportion of women experienced no withdrawal bleed at all, which was confirmed to be harmless.
A separate randomised controlled trial specifically evaluated Qlaira for heavy menstrual bleeding and found a statistically significant reduction in menstrual blood loss of approximately 80% compared with placebo.
This led to Qlaira receiving an additional marketing authorisation for the treatment of heavy menstrual bleeding in women who choose oral contraception as their method of contraception, without organic pathology.
The Faculty of Sexual and Reproductive Healthcare (FSRH) provides UK clinical guidance on contraceptive use.
FSRH guidelines on combined hormonal contraception cover eligibility, assessment, counselling, and management of missed pills.
The UK Medical Eligibility Criteria (UKMEC) should be applied before prescribing any combined hormonal contraceptive to identify women for whom the risks outweigh the benefits.
Qlaira compared with other combined pills
Conventional combined pills (such as Microgynon, Rigevidon, Yasmin, Marvelon) contain a fixed dose of ethinylestradiol (usually 20 to 35 micrograms) combined with a progestogen, taken for 21 days followed by a 7-day hormone-free interval.
Qlaira differs in three important ways: it uses natural oestrogen (estradiol valerate) instead of ethinylestradiol, it employs dynamic rather than fixed dosing, and it has only a 2-day hormone-free interval (the placebo tablets) rather than 7 days.
The shorter hormone-free interval may contribute to better ovarian suppression and cycle control.
For women who experience oestrogenic side effects (breast tenderness, nausea, headache, bloating) with ethinylestradiol-based pills, Qlaira may be better tolerated.
However, it is more complex to use: the tablets must be taken in the correct order, and missed-pill rules are more complicated than for fixed-dose pills.
Women who find pill-taking schedules difficult may prefer a fixed-dose pill or a long-acting method such as an IUD, implant, or injectable.
Dosage and administration
Take one Qlaira tablet daily at approximately the same time each day, in the order shown on the blister strip.
The colour-coded tablets are printed with the day of the week. Start a new strip immediately after the last white tablet, with no gap between strips.
Your withdrawal bleed, if it occurs, will usually begin during the last 2 to 4 tablets of the strip and may continue into the first days of the next strip.
If starting for the first time with no previous hormonal contraception, begin on day 1 of your menstrual period. No additional contraception is needed.
If starting between days 2 and 5, use condoms for the first 9 days.
If switching from another COC, start Qlaira the day after the last active tablet of the previous pill.
Detailed switching instructions are provided in the patient information leaflet and in FSRH guidance.
Missed pill rules for Qlaira are more complex than for fixed-dose pills because of the varying hormone content across the strip.
The key principle is: if any active (coloured) tablet is missed by more than 12 hours, use barrier contraception for the next 9 days and check the leaflet for specific guidance based on which tablet was missed.
If white (placebo) tablets are missed, simply discard them and continue as usual. Vomiting within 3 to 4 hours of taking a tablet counts as a missed dose.
Severe diarrhoea may also reduce absorption.
Side effects of Qlaira
Common side effects
Headache and breast tenderness are the most frequently reported side effects in clinical trials.
Irregular bleeding or spotting is common during the first 1 to 3 cycles and usually settles with continued use.
Some women experience very light or absent withdrawal bleeds, which is a normal feature of the formulation and does not indicate reduced contraceptive effectiveness.
Nausea, mood changes (including depressed mood), acne, and abdominal pain are other commonly reported effects.
Venous thromboembolism
All combined hormonal contraceptives carry a small increased risk of VTE.
The absolute risk is approximately 5 to 12 per 10,000 women per year during use, compared with approximately 2 per 10,000 in non-users.
The risk is highest during the first year of use and after restarting following a break of 4 weeks or more.
There are limited data specifically on the VTE risk of Qlaira compared with other COCs, but the MHRA advises that all combined hormonal contraceptives should be considered to carry similar risks.
Factors that increase VTE risk include obesity (BMI above 30), smoking, age over 35, family history of VTE, thrombophilia, and prolonged immobilisation.
Symptoms of DVT: sudden painful swelling, warmth, or redness in one leg. Symptoms of PE: sudden breathlessness, sharp chest pain, coughing blood. Call 999 immediately.
Other risks
The risk of arterial thromboembolism (heart attack, ischaemic stroke) is very slightly increased with COC use, particularly in women with additional risk factors (smoking, hypertension, diabetes, migraine with aura).
The risk of breast cancer is very slightly increased during current use and for up to 10 years after stopping, but the absolute increase is small.
Cervical cancer risk may be slightly increased with long-term use (more than 5 years), though this may be partly related to HPV exposure rather than the pill itself.
When to seek medical advice
Stop Qlaira and seek urgent help if you develop sudden leg pain or swelling, sudden breathlessness or chest pain, sudden severe headache unlike your usual headaches, sudden visual disturbance, sudden weakness or numbness on one side of the body, or jaundice.
Call 999 if you suspect DVT, PE, stroke, or heart attack.
Contact your GP or call NHS 111 for persistent mood changes, persistent irregular bleeding beyond the first 3 cycles, or any breast lumps.
Report suspected adverse reactions to the MHRA at yellowcard.mhra.gov.uk .
Warnings and precautions
Absolute contraindications
Qlaira must not be used in women with current or past VTE or arterial thromboembolic events, known thrombophilia, migraine with aura (current or historical), diabetes with vascular complications, severe or multiple cardiovascular risk factors, severe liver disease or liver tumours, known or suspected breast cancer or other sex-steroid-dependent malignancies, undiagnosed vaginal bleeding, pancreatitis with severe hypertriglyceridaemia, or hypersensitivity to any ingredient.
Risk assessment before prescribing
Your prescriber should assess BMI, blood pressure, smoking status, personal and family history of VTE and arterial disease, migraine history, and any other relevant medical conditions before prescribing Qlaira.
UKMEC categories guide eligibility. Regular reviews (at least annually) should reassess risk factors, blood pressure, and any new symptoms.
Interactions with other medicines
Enzyme-inducing medicines (rifampicin, carbamazepine, phenytoin, phenobarbital, primidone, topiramate above 200 mg/day, St John's wort, some antiretrovirals) reduce the effectiveness of Qlaira and may result in contraceptive failure.
Use an alternative method unaffected by enzyme inducers, or add barrier contraception during and for 28 days after the interacting medicine.
Broad-spectrum antibiotics (other than enzyme inducers such as rifampicin) do not reduce Qlaira's efficacy according to current FSRH guidance.
Fertility after stopping
Fertility typically returns rapidly after stopping Qlaira, often within 1 to 3 months. There is no evidence that prior use of combined oral contraception reduces long-term fertility.
How to get Qlaira in the UK
Qlaira is available on NHS prescription from your GP, sexual health clinic, or an authorised online prescriber registered with the General Pharmaceutical Council (GPhC).
All contraception is provided free of charge on the NHS, so there is no prescription charge.
Sexual health clinics (also called contraception clinics or family planning clinics) provide contraceptive services without the need for a GP referral.
Sources
- Qlaira, Summary of Product Characteristics (EMC)
- Estradiol with dienogest, British National Formulary (BNF)
- FSRH: Combined Hormonal Contraception
- Combined pill, NHS
- MHRA Yellow Card Scheme
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