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OpenTrials
Completed

NCT Number: NCT00631124

A Study to Evaluate Inhibition of Ovulation of Two Oral Estrogen/Progestogen Regimens in Healthy, Young Females Over a Period of 3 Treatment Cycles

Investigation of a new pill containing an estrogen and a progestin in order to monitor the inhibition of the ovulation in young healthy females over 3 treatment cycles

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Key information

Conditions

Contraception

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

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 female volunteers,
  • Age 18 - 35 years

Exclusion criteria

  • Contraindications for use of a combined (estrogen/progestogen) contraceptive (e.g. history of venous/arterial thromboembolic disease)
  • Regular intake of medication
  • Clinically relevant findings (ECG, blood pressure, physical, gynecological examination, laboratory examination)
  • Anovulatory pre-treatment cycle

Treatment and study plan

BAY86-4891 (Estradiol / Drospirenone)

Drug

Monophasic regimen containing estrogen and progestin 1 pre-treatment cycle, 3 treatment cycles

Primary outcomes

  1. The primary efficacy variable will be the proportion of volunteers with ovulation in at least one of the treatment cycles 2 and 3, based on the binary variable ovulation (i.e. Hoogland score 6) with the levels yes and no

    Time frame: 12 months

Secondary outcomes

  1. Assessment of ovarian activity in treatment cycles 2 and 3

    Time frame: 12 months

  2. Course of gonadotropins (FSH, LH)

    Time frame: 12 months

  3. Endometrial growth

    Time frame: 12 months

  4. Pharmacokinetics of estrogen and progestin in treatment cycle 3

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

A Double-blind, Randomized, Uncontrolled Study to Evaluate Inhibition of Ovulation of Two Oral Estradiol / Drospirenone Regimens in Healthy Young Female Volunteers Over a Period of 3 Treatment Cycles

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Mar 7, 2008
Registry last updated
Dec 2, 2014

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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