NCT03075956 is a Phase 1 clinical trial of 5 mg E4 single-dose in Contraception, sponsored by Estetra.

Who is sponsoring NCT03075956?

NCT03075956 is sponsored by Estetra.

What drugs are being tested in NCT03075956?

Interventions in NCT03075956: 5 mg E4 single-dose, 15 mg E4 single-dose, 45 mg E4 single-dose, 15 mg E4 multiple-dose.

What condition does NCT03075956 study?

NCT03075956 studies Contraception, Menopause.

Is NCT03075956 still recruiting?

NCT03075956 is currently completed. Last updated 8 September 2017.

Last reviewed 2017-09-08 · How we verify

NCT03075956

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

Safety, Tolerability and Pharmacokinetics of Estetrol (E4) After Single and Multiple Oral Doses in Healthy Female Volunteers

Completed Phase 1 Last updated 8 September 2017

What this trial tests

Phase 1 trial testing 5 mg E4 single-dose in Contraception in 31 participants. Completed in 2 August 2017.

Timeline

31 January 2017

Primary endpoint
2 August 2017

2 August 2017

Quick facts

Lead sponsor	Estetra
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	31
Start date	31 January 2017
Primary completion	2 August 2017
Estimated completion	2 August 2017
Sites	1 location across Bulgaria

Drugs / interventions tested

5 mg E4 single-dose — full drug profile →
15 mg E4 single-dose — full drug profile →
45 mg E4 single-dose — full drug profile →
15 mg E4 multiple-dose — full drug profile →

Conditions studied

Contraception — all drugs for Contraception →
Menopause — all drugs for Menopause →

Sponsor

Estetra — full company profile →

Who can join

Adults 18 to 55, female only, with Contraception or Menopause. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Estetrol (E4) is being developed in two indications supporting women health care: first E4 is combined with a progestin, \[drospirenone (DRSP)\] and is used as a new combined oral contraceptive (COC) for the prevention of pregnancy and secondly, E4 is used alone as new hormone replacement therapy (HRT) for the treatment of menopause related symptoms. The current clinical trial is designed to collect more detailed information about the PK profile, safety and tolerability of different dosages of E4, given orally as a solid tablet.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Comparison of Estetrol Exposure between Women and Mice to Model Preclinical Experiments and Anticipate Human Treatment.
Gallez A, Nys G, Wuidar V, Dias Da Silva I, et al · · 2023 · cited 5× · PMID 37298669 · DOI 10.3390/ijms24119718

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 Estetra trials

Trials by the same sponsor.

NCT06308614 — Estetrol for the Treatment of Female Sexual Arousal Disorder in Postmenopausal Women · Phase 2 · completed
NCT04819906 — Effect of Estetrol Monohydrate (E4) on QTc Interval · Phase 1 · completed
NCT04792385 — Safety, Compliance and Pharmacokinetics of Estetrol Monohydrate/Drospirenone 15/3 mg in Post-menarchal Female Adolescent · Phase 3 · completed
NCT04209543 — Estetrol for the Treatment of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women (E4Comfort Study I) · Phase 3 · completed
NCT04090957 — Estetrol for the Treatment of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women (E4Comfort II) · Phase 3 · completed

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 NCT03075956 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Estetra
Last refreshed: 8 September 2017

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/NCT03075956.

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