Who is sponsoring NCT01031355?

NCT01031355 is sponsored by Bayer.

What drugs are being tested in NCT01031355?

Interventions in NCT01031355: Estradiol Valerate (EV) / Levomefolate Calcium (BAY98-7078), Estradiol Valerate (EV) (BAY86-4980), Levomefolate Calcium (BAY86-7660).

What condition does NCT01031355 study?

NCT01031355 studies Contraception, Ovulation Inhibition.

Is NCT01031355 still recruiting?

NCT01031355 is currently completed. Last updated 18 February 2014.

Last reviewed 2014-02-18 · How we verify

NCT01031355

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 18 February 2014

What this trial tests

Phase 1 trial testing Estradiol Valerate (EV) / Levomefolate Calcium (BAY98-7078) in Contraception in 42 participants. Completed in 1 March 2010.

Timeline

1 December 2009

Primary endpoint
1 February 2010

1 March 2010

Quick facts

Lead sponsor	Bayer
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	42
Start date	1 December 2009
Primary completion	1 February 2010
Estimated completion	1 March 2010
Sites	1 location across Germany

Drugs / interventions tested

Estradiol Valerate (EV) / Levomefolate Calcium (BAY98-7078) — full drug profile →
Estradiol Valerate (EV) (BAY86-4980) — full drug profile →
Levomefolate Calcium (BAY86-7660) — full drug profile →

Conditions studied

Contraception — all drugs for Contraception →
Ovulation Inhibition — all drugs for Ovulation Inhibition →

Sponsor

Bayer — full company profile →

Who can join

Adults 45 to 75, female only, with Contraception or Ovulation Inhibition. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Contraception

Currently open trials in the same condition.

NCT07365904 — Investigating Ovulation Inhibition for Use as a Contraceptive · Phase 2 · recruiting
NCT07437495 — Women's Knowledge of Contraception During the Postpartum Period · active not recruiting
NCT06823037 — Hormonal Contraception Access Through Pharmacist Prescribing Implementation · NA · recruiting
NCT07326007 — Verbal Analgesia Versus Standard Technique for Pain Control During Copper T380A Intrauterine Device Insertion in Women W · NA · recruiting
NCT05910580 — Improving Alcohol and Substance Use Care Access, Outcome, Equity During the Reproductive Years · NA · recruiting

Other Bayer trials

Trials by the same sponsor.

NCT05900388 — A Study to Observe the Pattern of Use and Safety of Rivaroxaban in Children Under 2 Years Old With Venous Thromboembolis · not yet recruiting
NCT07490431 — An Observational Study to Learn More About How Elinzanetant is Used and How Well it Works for Women With Menopause Sympt · not yet recruiting
NCT05477953 — An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About · not yet recruiting
NCT07192952 — A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Child · Phase 3 · not yet recruiting
NCT07450599 — A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Befo · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01031355 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bayer
Last refreshed: 18 February 2014

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01031355.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing