CompletedPhase 2

Study to Assess the Efficacy and Safety of Three Dosage Strengths of Pulsatile GnRH Delivered From a Iontophoretic Patch Compared to Oral Treatment With Clomiphene or Placebo in Infertile Females

United States350 participantsStarted 2009-02

Plain-language summary

The primary objective of this study is to determine the safety and efficacy of pulsatile GnRH delivered from a iontophoretic patch (Lutrepatch) for induction of ovulation in women with anovulatory/ oligoovulatory infertility, compared to placebo and to a reference treatment with clomiphene citrate.

Who can participate

Age range18 Years – 38 Years

SexFEMALE

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Inclusion criteria

✓. Females between the ages of 18 and 38 years
✓. Desire to become pregnant
✓. Infertile due to ovulatory dysfunction as described below:

Exclusion criteria

✕. Requires donor oocytes or sperm
✕. Two or more failed (defined as no biochemical pregnancy achieved) gonadotropin fertility treatment cycles - if previous gonadotropin success, no more than two failed subsequent cycles
✕. Use of insulin-sensitizing drugs (e.g., Metformin) within 1 month prior to progesterone challenge

What they're measuring

Ovulation rate

Timeframe: 30 days

Trial details

NCT IDNCT00796289

SponsorFerring Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-12

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