Low Dose Continuous Administration of the Progesterone Receptor Modulator VA2914

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2004-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Contraception Gynecologic Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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VA2914

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes