check_circleStudy Completed

Ovulation Inhibition

Bayer Identifier:

91271

ClinicalTrials.gov Identifier:

NCT00805415

EudraCT Number:

Not Available

EU CT Number:

Not Available
Ovulation inhibition of two 4-phasic oral contraceptive regimens

Trial purpose

The aim of the study is to investigate the ovulation inhibition of two 4-phasic oral contraceptive regimens.

Key Participants Requirements

Sex

Female

Age

18 - 35 Years
  • - Healthy women willing to use non-hormonal methods of contraception
  • - Women with any contraindication for oral contraceptive use, for example but not limited to: presence or history of venous or arterial thrombotic / thrombembolic events, hypertension, presence or history of severe hepatic disease

Trial summary

Enrollment Goal
209
Trial Dates
March 2003 - February 2004
Phase
Phase 2
Could I Receive a placebo
No
Products
Natazia/Qlaira (EV/DNG, BAY86-5027)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Dinox GmbH BerlinBerlin, 10115, Germany
Completed
Dinox B.V.Groningen, 9713 GZ, Netherlands

Primary Outcome

  • Proportion of subjects with a Hoogland score of 5-6 (luteinized unruptured follicle [LUF] or ovulation)
    date_rangeTime Frame:
    Treatment cycles 2 and 3
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Proportion of subjects with a Hoogland score of 5-6 (LUF or ovulation)
    date_rangeTime Frame:
    Treatment cycles 2 or 3
    enhanced_encryption
    Safety Issue:
    no
  • Measurements of endometrial thickness
    date_rangeTime Frame:
    Treatment cycles 2 and 3
    enhanced_encryption
    Safety Issue:
    no
  • Visibility of cervical mucus
    date_rangeTime Frame:
    Treatment cycles 2 and 3
    enhanced_encryption
    Safety Issue:
    no
  • Ovarian activity (Hoogland score)
    date_rangeTime Frame:
    Posttreatment cycle (only subjects from center 2)Treatment cycles 2 and 3
    enhanced_encryption
    Safety Issue:
    no
  • Measurements of follicle size
    date_rangeTime Frame:
    Treatment cycles 2 and 3
    enhanced_encryption
    Safety Issue:
    No
  • Measurements of hormone levels (follicle-stimulating hormone [FSH], luteinizing hormone [LH], progesterone and estradiol)
    date_rangeTime Frame:
    Treatment cycles 2 and 3
    enhanced_encryption
    Safety Issue:
    No
  • Compliance
    date_rangeTime Frame:
    Throughout whole study
    enhanced_encryption
    Safety Issue:
    No
  • Medical, surgical and medication history, concomitant medication, general physical and gynecological examination, cervical smear, pregnancy test, adverse events, safety laboratory determinations, cycle control, vital signs
    date_rangeTime Frame:
    Various timepoint throughout the study
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

Multicenter, open-label, randomized, comparative study to evaluate ovulation inhibition with two 4-phasic oral contraceptive regimens containing estradiol valerate and dienogest applied daily for three cycles to 200 healthy female volunteer
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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