Exploratory Study Assessing Synchronisation of Egg Sacs With Degarelix

Ferring

Status and phase: Completed; Phase 2

Conditions: Infertility, Female

Treatments: Drug: Placebo; Drug: Degarelix mid-luteal, 2.5 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00434122

FE200486 CS24

Details and patient eligibility

About

The main purpose of this clinical research study is to investigate if degarelix can synchronise the growth of the egg sacs in the ovaries and if degarelix has any effect on the lining of the womb.

Full description

For the primary end-point (data collected on Stimulation Day 1), the study will compare degarelix 2.5 mg administered in the mid-luteal phase to placebo administered in the mid-luteal phase.

After Stimulation Day 1 the placebo group will be split into two groups: a degarelix 2.5 mg follicular group and a ganirelix 0.25 mg group.

Enrollment: 85 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Signed Informed Consent Form, prior to screening evaluations
• In good physical and mental health
• Pre-menopausal females between the ages of 18-35 years (both inclusive) at the time of randomisation
• Regular menstrual cycles of 26-35 days duration (both inclusive), presumed to be ovulatory
• Body mass index (BMI) between 18 and 29 kg/m2 (both inclusive)
• Willing to donate the retrieved oocytes
• Willing to use an adequate barrier method of contraception from informed consent to Day hCG injection +7 and to use an adequate barrier or hormonal method of contraception from Day hCG injection +7 to the end-of-study visit

Exclusion Criteria

• Abnormal karyotype
• Any known clinically significant systemic disease (e.g., insulin dependent diabetes)
• Any known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney) which can compromise participation in the study
• Diagnosed with polycystic ovarian syndrome or endometriosis stage III/IV
• Diagnosed as "poor responder"
• History of recurrent miscarriage (defined as three consecutive spontaneous losses before weeks 24 of pregnancy)
• Pregnancy or lactation
• Use of any investigational drug during 3 months prior to start of the current COH cycle
• Previous participation in the study
• Hypersensitivity to any trial product

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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85 participants in 2 patient groups, including a placebo group

Degarelix mid-luteal, 2.5 mg

Experimental group

Description:

Degarelix 2.5 mg will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak and on Stimulation Day 6. Placebo will be injected SC on Stimulation Day 1.

Treatment:

Drug: Degarelix mid-luteal, 2.5 mg

Placebo

Placebo Comparator group

Description:

Placebo will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak. Degarelix 2.5 mg will be injected SC on Stimulation Day 1 and Stimulation Day 6. or Placebo will be injected SC 7 days after LH peak and on Stimulation Day 1. Ganirelix 0.25 mg will be injected SC daily from Stimulation Day 6 until the last stimulation day.

Treatment:

Drug: Placebo