Clinical trial NCT01076582: Comparative Trial in Hormone Withdrawal Associated Symptoms
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Oral Contraceptive
Keywords: hormone withdrawal associated symptoms
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2010-02-26
Enrollment: 592
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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).

Primary outcomes:
measure: 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 outcomes:
measure: 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
measure: 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
measure: 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
measure: rescue medication consumption
timeFrame: baseline cycle and cycle 4
measure: bleeding pattern
timeFrame: reference period is 90 days.
measure: evaluation of questionnaires: Q-LES-Q (short version)
timeFrame: baseline cycle and cycle 4
measure: Adverse Event collection
timeFrame: up to 10 days after end of cycle 4
measure: heart rate
timeFrame: up to 10 days after end of cycle 4
measure: blood pressure
timeFrame: up to 10 days after end of cycle 4
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
state: Ciudad Auton. de Buenos Aires
city: Rosario
country: Argentina
state: Santa Fe
city: Santiago de Chile
country: Chile
state: Santiago
city: Santiago de Chile
country: Chile
city: Santiago
country: Chile
city: Santiago
country: Chile
city: Santiago
country: Chile
city: Temuco
country: Chile
city: Bucaramanga
country: Colombia
state: Santander
city: Bogotá
country: Colombia
city: Medellín
country: Colombia
city: Brno
country: Czech Republic
city: Praha 2
country: Czech Republic
city: Tabor
country: Czech Republic
city: Heidelberg
country: Germany
state: Baden-Württemberg
city: Fürth
country: Germany
state: Bayern
city: Hannover
country: Germany
state: Niedersachsen
city: Magdeburg
country: Germany
state: Sachsen-Anhalt
city: Leipzig
country: Germany
state: Sachsen
city: Jena
country: Germany
state: Thüringen
city: Firenze
country: Italy
city: Milano
country: Italy
city: Siena
country: Italy
city: Seoul
country: Korea, Republic of
state: Korea
city: Seoul
country: Korea, Republic of
state: Korea
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Manila
country: Philippines
city: Pasig City
country: Philippines
city: Coimbra
country: Portugal
city: Lisboa
country: Portugal
city: Porto
country: Portugal
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Basel
country: Switzerland
state: Basel-Stadt
city: St. Gallen
country: Switzerland
state: Sankt Gallen
city: Bern
country: Switzerland
city: Bangkok
country: Thailand
city: Bangkok
country: Thailand
city: Songkla
country: Thailand
city: Leeds
country: United Kingdom
state: West Yorkshire
city: Liverpool
country: United Kingdom
city: London
country: United Kingdom
city: Caracas
country: Venezuela
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: