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Completed

NCT Number: NCT00805415

Ovulation Inhibition of Two 4-phasic Oral Contraceptive Regimens

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

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Key information

Conditions

Ovulation Inhibition

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Dinox GmbH Berlin, Berlin, State of Berlin, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy women willing to use non-hormonal methods of contraception

Exclusion criteria

  • 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

Treatment and study plan

EV/DNG (Qlaira, BAY86-5027, SH T00658K)

Drug

Estradiol valerate (EV) and dienogest (DNG) in a sequential 4-phasic regimen, EV 3, 2, and 1 mg and DNG 2 and 3 mg

EV/DNG (SH T00658L)

Drug

Estradiol valerate (EV) and dienogest (DNG) in a sequential 4-phasic regimen, EV 3, 2, and 1 mg and DNG 3 and 4 mg

Primary outcomes

  1. Proportion of subjects with a Hoogland score of 5-6 (luteinized unruptured follicle [LUF] or ovulation)

    Time frame: Treatment cycles 2 and 3

Secondary outcomes

  1. Proportion of subjects with a Hoogland score of 5-6 (LUF or ovulation)

    Time frame: Treatment cycles 2 or 3

  2. Measurements of endometrial thickness

    Time frame: Treatment cycles 2 and 3

  3. Visibility of cervical mucus

    Time frame: Treatment cycles 2 and 3

  4. Ovarian activity (Hoogland score)

    Time frame: Posttreatment cycle (only subjects from center 2)Treatment cycles 2 and 3

  5. Measurements of follicle size

    Time frame: Treatment cycles 2 and 3

  6. Measurements of hormone levels (follicle-stimulating hormone [FSH], luteinizing hormone [LH], progesterone and estradiol)

    Time frame: Treatment cycles 2 and 3

  7. Compliance

    Time frame: Throughout whole study

  8. 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

    Time frame: Various timepoint throughout the study

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Dec 9, 2008
Registry last updated
Jul 15, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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