Jadelle - staafjes met levonorgestrel

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mo
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Lid geworden op: 03-01-2008 10:55

Jadelle - staafjes met levonorgestrel

Bericht door mo » 04-08-2009 09:39

http//www.popcouncil.org/pdfs/jadelle_monograph.pdf

Dit gaat over Jadelle, staafjes met levonorgestrel die in de arm worden geplaatst, vergelijkbaar met Norplant. De Mirena bevat ook alleen levonorgestrel, dus het is wel interessant om naar de bijwerkingen van Jadelle te kijken, zie tabel 5 op pagina 14 (bijwerkingen die tijdens clinical trials zijn gemeld)

Table 5. Adverse reactions during five years of Jadelle use in clinical trials
Adverse reactions reported by 10% or more of women
Application site reaction, pain, etc.
Dizziness
Headache
Leukorrhea
Mastalgia
Nausea
Pelvic pain
Urinary tract symptoms, infection
Vaginitisa
Weight increase
a includes also genital pruritus, infections, and vaginal problems not elsewhere classified)

Adverse reactions reported by 1.0 to 9.9% of women
Abdominal pain
Abnormal vision
Acne
Alopecia
Anorexia
Anxiety
Appetite increase
Asthenia
Asthma
Back pain
Benign breast neoplasm
Breast fibroadenosis
Bronchitis
Cervical cytology, grade 3 or 4
Cervical lesion
Cervicitis
Chest pain
Constipation, flatulence, or dyspepsia
Contact dermatitis
Depression
Dermatitis
Dyspareunia
Dyspnea
Emotional lability
Fatigue
Flu-like symptoms
Folliculitis
Hypertension
Hypertrichosis
Hypoesthesia
Injury
Insomnia
Libido decreased
Migraine
Nervousness
Nonpuerperal lactation
Ovarian cyst, follicle enlargement
Pain
Palpitation
Perineal pain
Pruritus
Purpura
Rash
Somnolence
Syncope
Upper respiratory infectionb
Uterine enlargement
Varicose veins
Vomiting
Vulvar disorderc
Weight decrease
b includes rhinitis, pharyngitis, and sinusitis, as well as undefined upper respiratory infection
c includes genital ulceration, herpes simplex, and papilloma virus and other vulvar disorders

Pagina 23 Medical occurrences most frequently cited as reasons for removal were headaches, depression, weight gain, or hair loss.

Pagina 26 38. What are the most common side effects reported with Jadelle use?
The most common side effect of Jadelle use is irregular menstrual bleeding—most women can expect some variation in menstrual bleeding patterns. Irregularities vary from woman to woman and may include prolonged menstrual bleeding (more days than a woman would normally experience), heavy bleeding, prolonged spotting or spotting between periods, no bleeding at all, or a combination of these patterns.
Other adverse reactions reported by 10 percent or more of women during five years of Jadelle use in clinical trials were application site reaction, discoloration, or pain; dizziness; headache; leukorrhea (whitish discharge from the vagina and uterine cavity); mastalgia (breast pain); nausea; pelvic pain; urinary tract symptoms; vaginitis (including genital pruritus and infections); and weight gain.
Women using Jadelle have also experienced acne, appetite changes, contact dermatitis, hair loss, lesions or inflammation of the cervix, libido decrease, and nervousness.
Preexisting conditions of acne or excessive growth of body or facial hair could worsen.

Pagina 28 49. Does Jadelle use increase blood pressure?
Increased blood pressure has been reported in users of combined oral contraceptives. The prevalence of elevated blood pressure increases with long exposure. Although no clinically significant rises in mean blood pressure occurred among Jadelle users in clinical trials, physicians should be aware of the possibility of elevated blood pressure in women using this method.

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