A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Three Dosage Strengths of Pulsatile GnRH

• Status: Completed
• Trial end date: 2005-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

This study will be performed in approximately 132 women with anovulatory/oligoovulatory infertility.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ferring Pharmaceuticals
• Treatments: Citric Acid; Clomiphene; Enclomiphene; Hormones; Prolactin Release-Inhibiting Factors; Sodium Citrate; Zuclomiphene

Criteria

Inclusion Criteria

1. Females between the ages of 18 (or 19 in the State of Alabama) and 40 years.

2. Infertile due to ovulatory dysfunction as described below:

3. Positive progesterone withdrawal test following the screening visit.

4. TSH (thyroid-stimulating hormone) levels within normal limits for the clinical laboratory or considered not clinically significant (eg, secondary to exogenous thyroid medication) by the investigator

5. Normal insulin sensitivity assessed as ratio of fasting blood glucose to fasting insulin > 4.5 at Screening

6. Male partner with recent (within 6 months prior to screening) semen analysis showing normalcy according to the local laboratory normal criteria. If screening semen analysis is borderline, the couple will be accepted into the study only if a second sample obtained prior to screening is adequate.

7. Presence of both ovaries, without evidence of clinically significant abnormality, as detected by transvaginal ultrasound

8. Normal transvaginal ultrasound with respect to uterus and adnexa (eg, no hydrosalpinx)

9. Hysterosalpingography or hysteroscopy or sonohysterogram documenting a uterine cavity consistent with expected normal function and patency of the fallopian tubes within the previous 3 years prior to screening (within 1 year prior to screening there should be no pelvic infection, endometriosis or pelvic surgery).

10. Negative serum pregnancy test (qualitative) prior to the progesterone test

11. Desire to become pregnant

Exclusion Criteria

1. Requires donor oocytes or sperm

2. Previous and current use of infertility modifiers, including insulin-sensitizing drugs

3. Primary amenorrhea/hypogonadotropic hypogonadism (eg, isolated gonadotropin deficiency or evidence of primary/premature ovarian failure)

4. Presence of any clinically relevant systemic disease (eg, diabetes mellitus, pituitary tumor, anorexia nervosa).

5. Surgical or medical condition which in the judgment of the Investigator or Sponsor may interfere with absorption, distribution, metabolism, or excretion of the drugs to be used.

6. Any pregnancy within last 3 months prior to Screening.

7. Patients with a body mass index (BMI) >30 at time of Screening

8. Total testosterone and DHEA-S >1.5 times the upper limits of normal laboratory range and prolactin > 20 ng/mL

9. Presence of abnormal uterine bleeding of undetermined origin.

10. Active or prior history of substance abuse

11. History of chemotherapy (except for gestational conditions) or radiotherapy

12. Currently breast feeding, pregnant or contraindication to pregnancy

13. Refusal or inability to comply with the requirements of the Protocol for any reason, including scheduled clinic visits and laboratory tests.

14. Documented intolerance or allergy to any of the medications used including the study medication

15. Participation in any experimental drug study within 60 days prior to Screening