Trial Condition(s):
Oral Contraceptive
Comparative trial in hormone withdrawal associated symptoms
Bayer Identifier:
14567
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
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.
Inclusion Criteria
- 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
Exclusion Criteria
- 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).
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Praxis Fr. Dr. B. Fechtel Jena, Germany, 07747 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Queen Charlottes & Chelseas Hospital London, United Kingdom, W12 0HS | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Careggi Firenze, Italy, 50134 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS Fondazione San Raffaele Milano, Italy, 20132 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nestatni zdravotnicke zarizeni MUDr. Vladimir Dvorak Brno, Czech Republic, 602 00 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr. Smrhova-Kovacs Tabor, Czech Republic, 39003 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro Hospitalar de Lisboa Norte - Hospital Santa Maria Lisboa, Portugal, 1649-035 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sanatorio MAPACI Rosario, Argentina, 2000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Clínico Universidad de Chile Santiago, Chile, 838-0456 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Corporación SERJOVEN Santiago, Chile | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro de Investigación Clinica Universidad del Rosario Bogotá, Colombia | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Endocrinology Scientific Centre Moscow, Russia, 117036 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Scientific Research Center of Obst., Gyn. and Perinatology Moscow, Russia, 177997 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations City Clinical Hospital no 72 Moscow, Russia, 123995 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Heidelberg Heidelberg, Germany, 69115 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. K. Greven Hannover, Germany, 30459 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations EuromedClinic Fürth, Germany, 90763 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Leeds Student Medical Practice Leeds, United Kingdom, LS2 9AE | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Senese Siena, Italy, 53100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Gynprofi s.r.o. Praha 2 , Czech Republic, 120 00 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Maternidade Bissaya Barrreto Coimbra, Portugal, 3000-061 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital de São João Porto, Portugal, 4200-319 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Bernardino Rivadavia Buenos Aires, Argentina, C1425ASQ | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Consultorio Miraflores Temuco, Chile, 4790711 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Consultorio Dr. Vera Santiago, Chile, 7510025 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fundación Centro de Investigación Clinica Medellín, Colombia | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Samsung Medical Center Seoul , South Korea, 135-710 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Seoul National University Hospital Seoul, South Korea, 110-744 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cheil general Hospital Seoul, South Korea, 100-380 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsspital Basel Basel, Switzerland, 4031 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Inselspital Bern Bern, Switzerland, 3010 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Medical City Pasig City, Philippines | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Siriraj Hospital, Mahidol Bangkok, Thailand, 10700 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations King Chulalongkorn Memorial Hospital Bangkok, Thailand, 10330 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Prince of Songkla University Songkla, Thailand, 90110 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Asan Medical Center Seoul, South Korea, 138-736 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kantonsspital St. Gallen St. Gallen, Switzerland, 9007 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clínica Santa Sofía Caracas, Venezuela | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Policlínica Metropolitana Caracas, Venezuela | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro Médico Docente La Trinidad Caracas, Venezuela | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations UP Manila PGH Manila, Philippines | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations May Logan Centre Liverpool, United Kingdom, L20 5DQ | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Prof. Dr. H.-J. Ahrendt Magdeburg, Germany, 39126 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr. Juan Carolos Montero Santiago de Chile, Chile | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Instituto Chileno de Medicina Reproductiva Santiago de Chile, Chile | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Clínico San Borja Arriarán Santiago de Chile, Chile, 836-0156 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Frauenarztpraxis Dr. Bernd Pittner Leipzig, Germany, 04207 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ICAMEDIC Bucaramanga, Colombia | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clínica Medellín Medellín, Colombia | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clínica del Country Bogotá, Colombia | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Primary Outcome
- Change from baseline to cycle 4 in the sum of composite score during cycle days 22 - 28. The composite score comprises headache, pelvic pain and bloating (each measured by 7-point Likert scales).Timeframe: Cycle days 22 - 28 of baseline cycle and cycle 4.
Secondary Outcome
- change from baseline to cycle 4 in the sum of individual scores during cycle days 22 - 28 (AUC of days 22 - 28 for each score),Timeframe: Cycle days 22 - 28 of baseline cycle and cycle 4
- change from baseline to cycle 4 in number of days, where individual hormone withdrawal symptoms are present on cycle days 22 - 28 (i.e. Likert Scale >= 1),Timeframe: Cycle days 22 - 28 of baseline cycle and cycle 4
- change from baseline to cycle 4 in maximum intensity of individual hormone withdrawal symptoms on cycle days 22 - 28,Timeframe: Cycle days 22 - 28 of baseline cycle and cycle 4
- rescue medication consumptionTimeframe: baseline cycle and cycle 4
- bleeding patternTimeframe: reference period is 90 days.
- evaluation of questionnaires: Q-LES-Q (short version)Timeframe: baseline cycle and cycle 4
- Adverse Event collectionTimeframe: up to 10 days after end of cycle 4
- heart rateTimeframe: up to 10 days after end of cycle 4
- blood pressureTimeframe: up to 10 days after end of cycle 4
Additional Information
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