Low Dose Continuous Administration of the Progesterone Receptor Modulator VA2914

Prospective Randomized Multicenter Phase II Study of the Dose-Response Effects of Continuous Administration of Low-Dose VA2914 on Parameters of the Hypothalamic-Pituitary-Gonadal Axis and the Endometrium

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00456924

Enrollment

Registered

2007-04-05

Start date

2004-01-31

Completion date

2004-12-31

Last updated

2010-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception, Gynecologic Diseases

Keywords

progesterone receptor modulator

Brief summary

The purpose of the present study is to evaluate continuous administration of low doses of VA2914 for potential contraceptive activity and effects on the menstrual cycle and steroid hormone parameters.

Interventions

DRUGVA2914

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 35 Years

Healthy volunteers

Yes

Inclusion criteria

* women in good general health with regular, ovulatory menstrual cycles * age 18-35 * not pregnant * not sexually active or reliably use barrier methods of contraception * normal liver and renal functions and normal laboratory exams

Exclusion criteria

* pregnant or breastfeeding * oral contraception, IUD or other hormonal treatment * use of agents known to induce hepatic P450 * cardiovascular disorder * hepatic, renal, or gastrointestinal disorder * metrorrhagia * abnormal transvaginal ultrasound (at baseline) * history of abnormal endometrial biopsy, * cancer * depression * mental illness * epilepsy * migraines * abnormal Pap Smear requiring further exploratory examination * anovulatory cycle before treatment * extreme overweight or underweight (body mass index \< 16 ou \>28) * subjects unlikely to comply with the protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study * use of narcotics * more than 10 cigarettes per day, more than 2 glasses of wine/beer per day * surgical procedures planned in the 6 months following screening visit

Design outcomes

Primary

Measure	Time frame
ovarian hormones	—
follicular development	—
endometrial histology	—

Secondary

Measure	Time frame
adverse events	—
menstural bleeding patterns	—
laboratory parameters	—
cervical mucus	—
VA2914 concentration	—

Countries

Belgium, France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026