Trial Condition(s):
Comparative trial in hormone withdrawal associated symptoms
14567
Not Available
Not Available
This clinical research study will examine whether an oral contraceptive pill taken with a monthly hormone-free interval of 4 days reduces hormone withdrawal associated symptoms compared to an oral contraceptive pill taken with a monthly hormone-free interval of 7 days after 4 cycles of treatment.
- Subjects aged between 18 and 35 years (inclusive) - Smokers with a maximum age of 30 years at time of informed consent - Healthy female subjects requesting contraception and currently using a low-dose EE containing oral contraceptives (OC) in a 21-day regimen (for at least three months) and suffering from at least two of the hormone withdrawal associated symptoms headache, pelvic pain and bloating during all three months prior the planned baseline cycle and requiring further OC use - To be valid for randomization, the total 7-day composite score of hormone-withdrawal symptoms during the baseline cycle must show an increase of at least 50% during Day 22 - 28 versus the 21-day composite score during Day 1 - 21 (21-day score divided by three [for normalization]) - History of regular cyclic menstrual periods
- Presence or a history of venous or arterial thrombotic/thromboembolic events (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident, or presence or history of prodrome of a thrombosis (e.g. transient ischemic attack, angina pectoris) and conditions that could increase the risk to suffer from any of the above mentioned disorders, e.g., a family history indicating a hereditary predisposition. Hereditary or acquired predisposition for venous or arterial thrombosis, such as APCresistance, antithrombin-III-deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid-antibodies (anticardiolipin-antibodies, lupus anticoagulant). - History of migraine with focal neurological symptoms. - Diabetes mellitus with vascular involvement. - Obesity (Body Mass Index >32.0 kg/m2) - Moderate to severe hypertension (repeated measurements of systolic blood pressure >140 mmHg and/or diastolic blood pressure >90 mmHg). - Pancreatitis or a history thereof if associated with severe hypertriglyceridemia. - Presence or history of severe hepatic disease as long as liver function values have not returned to normal. - Jaundice and / or pruritus related to cholestasis (Gilbert´s syndrome excepted), or history of cholestatic jaundice associated with pregnancy or previous combined OC use - Severe renal insufficiency or acute renal failure. - Presence or history of liver tumors (benign or malignant), or known or suspected sex-steroid influenced malignancies or premalignant disease (e.g. of the genital organs or the breasts).
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Locations Investigative Site Jena, Germany, 07747 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site London, United Kingdom, W12 0HS | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Firenze, Italy, 50134 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Milano, Italy, 20132 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Brno, Czech Republic, 602 00 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tabor, Czech Republic, 39003 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lisboa, Portugal, 1649-035 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Rosario, Argentina, 2000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Santiago, Chile, 838-0456 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Santiago, Chile | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bogotá, Colombia | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Moscow, Russia, 117036 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Moscow, Russia, 177997 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Moscow, Russia, 123995 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Heidelberg, Germany, 69115 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hannover, Germany, 30459 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Fürth, Germany, 90763 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Leeds, United Kingdom, LS2 9AE | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Siena, Italy, 53100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Praha 2 , Czech Republic, 120 00 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Coimbra, Portugal, 3000-061 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Porto, Portugal, 4200-319 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Buenos Aires, Argentina, C1425ASQ | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Temuco, Chile, 4790711 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Santiago, Chile, 7510025 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Medellín, Colombia | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seoul , South Korea, 135-710 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seoul, South Korea, 110-744 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seoul, South Korea, 100-380 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Basel, Switzerland, 4031 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bern, Switzerland, 3010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pasig City, Philippines | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bangkok, Thailand, 10700 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bangkok, Thailand, 10330 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Songkla, Thailand, 90110 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seoul, South Korea, 138-736 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St. Gallen, Switzerland, 9007 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Caracas, Venezuela | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Manila, Philippines | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Liverpool, United Kingdom, L20 5DQ | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Magdeburg, Germany, 39126 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Santiago de Chile, Chile | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Santiago de Chile, Chile, 836-0156 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Leipzig, Germany, 04207 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bucaramanga, Colombia | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Medellín, Colombia | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bogotá, Colombia | Contact Us: E-mail: [email protected] Phone: Not Available |
A multi-centre, randomized, double-blind, active control, parallel-group, 2-arm study to investigate the effect of ethinylestradiol / drospirenone (0.02 mg/3 mg) oral contraception in a 24/4 regimen compared to ethinylestradiol / desogestrel (0.02 mg/0.15 mg) oral contraception in a 21/7 regimen on hormone withdrawal associated symptoms in otherwise healthy women after 4 cycles of treatment
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2