Comparative Trial in Hormone Withdrawal Associated Symptoms

NCT01076582 | Completed Phase 3

• 2 other identifiers: 145672009-014911-11
• Study Type: interventional
• Target: 592
• Locations: 14 countries
• Sites: 44

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.

Conditions

Oral Contraceptive

Keywords

hormone withdrawal associated symptoms

Outcome Measures

Primary Outcomes (1)

• 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).

  Cycle days 22 - 28 of baseline cycle and cycle 4.

Secondary Outcomes (9)

• 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),

  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),

  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,

  Cycle days 22 - 28 of baseline cycle and cycle 4

• rescue medication consumption

  baseline cycle and cycle 4

• bleeding pattern

  reference period is 90 days.

Study Arms (2)

Arm 1

EXPERIMENTAL

Drug: EE20/DRSP (YAZ, BAY86-5300)

Arm 2

ACTIVE COMPARATOR

Drug: Ethinylestradiol (EE) and desogestrel (DSG) (Mercilon)

Interventions

EE20/DRSP (YAZ, BAY86-5300) DRUG

4 cycles of treatment / per cycle: 1 tablet (EE 0.02 mg / DRSP 3 mg) daily for 24 days followed by 1 placebo tablet daily for 4 days

Arm 1

Ethinylestradiol (EE) and desogestrel (DSG) (Mercilon) DRUG

4 cycles of treatment / per cycle: 1 tablet (EE 0.02 mg / DSG 0.15 mg) daily for 21 days followed by 1 placebo tablet daily for 7 days

Arm 2

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Bayer: lead

Study Sites (44)

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Buenos Aires, Ciudad Auton. de Buenos Aires, C1425ASQ, Argentina

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Rosario, Santa Fe Province, 2000, Argentina

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Santiago, Santiago Metropolitan, 7510025, Chile

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Santiago, Santiago Metropolitan, 836-0156, Chile

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Santiago, 838-0456, Chile

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Santiago, Chile

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Temuco, 4790711, Chile

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Bucaramanga, Santander Department, Colombia

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Bogotá, Colombia

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Medellín, Colombia

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Brno, 602 00, Czechia

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Prague, 120 00, Czechia

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Tábor, 39003, Czechia

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Heidelberg, Baden-Wurttemberg, 69115, Germany

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Fürth, Bavaria, 90763, Germany

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Hanover, Lower Saxony, 30459, Germany

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Leipzig, Saxony, 04207, Germany

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Magdeburg, Saxony-Anhalt, 39126, Germany

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Jena, Thuringia, 07747, Germany

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Florence, 50134, Italy

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Milan, 20132, Italy

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Siena, 53100, Italy

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Manila, Philippines

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Pasig, Philippines

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Lisbon, Lisbon District, 1649-035, Portugal

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Coimbra, 3000-061, Portugal

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Porto, 4200-319, Portugal

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Moscow, 117036, Russia

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Moscow, 123995, Russia

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Moscow, 177997, Russia

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Seoul, Korea, 100-380, South Korea

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Seoul, Korea, 138-736, South Korea

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Seoul, 110-744, South Korea

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Seoul, 135-710, South Korea

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Basel, Canton of Basel-City, 4031, Switzerland

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Bern, Canton of Bern, 3010, Switzerland

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Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

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Bangkok, Thailand, 10330, Thailand

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Songkhla, Thailand, 90110, Thailand

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Bangkok, 10700, Thailand

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Leeds, West Yorkshire, LS2 9AE, United Kingdom

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Liverpool, L20 5DQ, United Kingdom

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London, W12 0HS, United Kingdom

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Caracas, Venezuela

Location

Related Links

• Click here to find information about studies related to Bayer Healthcare products conducted in Europe

MeSH Terms

Interventions

drospirenone and ethinyl estradiol combination; Ethinyl Estradiol; Desogestrel; ethinyl estradiol-desogestrel combination

Intervention Hierarchy (Ancestors)

Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Norpregnenes

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2010
• First Posted: February 26, 2010
• Study Start: April 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: October 28, 2014

Record last verified: 2014-10

Locations

CL (5); DE (6); PH (2); CZ (3); PT (3); AR (2); RU (3); KR (4); CH (3); CO (3); IT (3); TH (3); GB (3); VE (1)