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OpenTrials
Completed

NCT Number: NCT01031355

Bioequivalence Study: 3 mg Estradiol Valerate (EV) With and Without Levomefolate Calcium

Investigation of the bioequivalence (BE) of Estradiol Valerate (EV) after administration of one film-coated tablet containing 3 mg Estradiol Valerate and 0.451 mg Levomefolate calcium as compared to one film-coated tablet containing 3 mg Estradiol Valerate Investigation of the bioequivalence of levomefolate calcium after administration of one film-coated tablet containing 3 mg Estradiol Valerate and 0.451 mg Levomefolate calcium as compared to one film-coated tablet containing 0.451 mg levomefolate calcium

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Key information

Conditions

Contraception Ovulation Inhibition

Age range

45 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Neu-Ulm, Bavaria, 89231, Germany

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • BMI:>18 <30 kg/m²
  • Healthy female volunteers
  • Age 45-75 years
  • Postmenopausal state

Exclusion criteria

  • Contraindications for use of combined (Estradiol Valerate/dienogest) contraceptive (e.g.history of venous/arterial thromboembolic disease)
  • Regular intake of medication
  • Clinically relevant findings (ECG, blood pressure, physical and gynaecological examination, laboratory examination)
  • Smoking

Treatment and study plan

Estradiol Valerate (EV) / Levomefolate Calcium (BAY98-7078)

Drug

Oral, single dose, 3 mg EV + 0.451 mg levomefolate calcium, washout phase between treatments: at least 7 days

Estradiol Valerate (EV) (BAY86-4980)

Drug

Oral, single dose, 3 mg EV, washout phase between treatments: at least 7 days

Levomefolate Calcium (BAY86-7660)

Drug

Oral, single dose, 0.451 mg levomefolate calcium, washout phase between treatments: at least 7 days

Primary outcomes

  1. Uncorrected Cmax and AUC(0-tlast) and baseline corrected Cmax and AUC (if possible) for E1, E2, E1S, and L-5- methyl-THF

    Time frame: 2 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Open-label, Randomized, Cross-over Study to Investigate the Bioequivalence of Estradiol Valerate (EV) and Levomefolate Calcium After Single Oral Administration of a Tablet Formulation Containing 3 mg EV Without and With 0.451 mg Levomefolate Calcium and a Tablet Formulation Containing 0.451 mg Levomefolate Calcium in 42 Healthy Postmenopausal Women

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 14, 2009
Registry last updated
Feb 20, 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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