AS900672-Enriched in Ovulation Induction

NCT00553514 | Terminated Phase 2 Results

• 1 other identifier: 27818
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 2, interventional, multi-center, randomized, assessor-blind, active-comparator, dose-finding study to evaluate a new investigational long-acting follicle stimulating hormone (FSH) in oligo-anovulatory women undergoing ovulation induction (OI). This study will compare 4 doses of the investigational drug versus a currently marketed drug follitropin alfa (Gonal-f ®) prefilled pen with regards to ovulation rate.

Conditions

Ovulation Induction

Keywords

Infertility; Oligo-anovulation; GONAL-f®; AS900672-Enriched; hyperglycosylated recombinant human follicle stimulating hormone (r-hFSH)

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Ovulation

  Ovulation was defined as a mid-luteal phase progesterone (P4) level \>= 30 nanomole per liter (nmol/L) (10 nanogram per milliliter \[ng/mL\]). In the absence of a positive progesterone response, clinical pregnancy was also considered as evidence of ovulation.

  Mid-luteal phase progesterone assessed 5-10 days or clinical pregnancy 35-42 days after recombinant human chorionic gonadotropin (r-hCG) administration day (end of stimulation cycle [approximately 14 days])

Secondary Outcomes (5)

• Percentage of Participants With Clinical Pregnancy

  Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])

• Duration of Ovarian Stimulation

  Stimulation Day 1 (S1) up to r-hCG administration day (end of stimulation cycle [approximately 14 days])

• Duration of Supplemental Follitropin Alfa Treatment

  Stimulation Day 7 (S7) up to r-hCG administration day (end of stimulation cycle [approximately 14 days])

• Cumulative Dose of Supplemental Follitropin Alfa Administered

  Stimulation Day 7 (S7) up to r-hCG administration day (end of stimulation cycle [approximately 14 days])

• Number of Follicles With Mean Diameter Less Than (<) 11 Millimeter (mm) and Greater Than or Equal to (>=) 11 mm

  Stimulation Day 5 (S5), S7 and r-hCG administration day (end of stimulation cycle [approximately 14 days])

Study Arms (5)

AS900672-Enriched 10 mcg

EXPERIMENTAL

Drug: AS900672-Enriched 10 microgram (mcg); Drug: Follitropin alfa 75 international unit (IU); Drug: Recombinant human chorionic gonadotropin (r-hCG)

AS900672-Enriched 20 mcg

EXPERIMENTAL

Drug: AS900672-Enriched 20 mcg; Drug: Follitropin alfa 75 international unit (IU); Drug: Recombinant human chorionic gonadotropin (r-hCG)

AS900672-Enriched 30 mcg

EXPERIMENTAL

Drug: AS900672-Enriched 30 mcg; Drug: Follitropin alfa 75 international unit (IU); Drug: Recombinant human chorionic gonadotropin (r-hCG)

AS900672-Enriched 40 mcg

EXPERIMENTAL

Drug: AS900672-Enriched 40 mcg; Drug: Follitropin alfa 75 international unit (IU); Drug: Recombinant human chorionic gonadotropin (r-hCG)

Follitropin alfa 75 IU

ACTIVE COMPARATOR

Drug: Follitropin alfa 75 international unit (IU); Drug: Recombinant human chorionic gonadotropin (r-hCG)

Interventions

AS900672-Enriched 10 microgram (mcg) DRUG

Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone \[r-hFSH\]), 10 mcg will be administered subcutaneously on Stimulation Day 1 (S1). Duration of treatment cycle will be up to adequate follicular response received or maximum of 14 days.

Also known as: Hyperglycosylated r-hFSH

AS900672-Enriched 10 mcg

AS900672-Enriched 20 mcg DRUG

Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 20 mcg will be administered subcutaneously on S1. Duration of treatment cycle will be up to adequate follicular response received or maximum of 14 days.

Also known as: Hyperglycosylated r-hFSH

AS900672-Enriched 20 mcg

AS900672-Enriched 30 mcg DRUG

Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 30 mcg will be administered subcutaneously on S1. Duration of treatment cycle will be up to adequate follicular response received or maximum of 14 days.

Also known as: Hyperglycosylated r-hFSH

AS900672-Enriched 30 mcg

AS900672-Enriched 40 mcg DRUG

Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 40 mcg will be administered subcutaneously on S1. Duration of treatment cycle will be up to adequate follicular response received or maximum of 14 days.

Also known as: Hyperglycosylated r-hFSH

AS900672-Enriched 40 mcg

Follitropin alfa 75 international unit (IU) DRUG

Follitropin alfa (Gonal-f®) 75 IU will be administered subcutaneously once daily from S1 up to Stimulation Day 14 (S14) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. Subjects who will be receiving AS900672-Enriched 10, 20, 30 and 40 mcg will also receive daily dose of follitropin alfa 75 IU subcutaneously from Stimulation Day 7 (S7) up to S14. Duration of treatment cycle will be up to adequate follicular response received or maximum of 14 days.

Also known as: Gonal-f®, Follicle stimulating hormone (FSH)

AS900672-Enriched 10 mcg; AS900672-Enriched 20 mcg; AS900672-Enriched 30 mcg; AS900672-Enriched 40 mcg; Follitropin alfa 75 IU

Recombinant human chorionic gonadotropin (r-hCG) DRUG

Recombinant human chorionic gonadotropin (r-hCG) will be administered as a single dose of 250 mcg subcutaneously, when follicular response is adequate (that is, less than or equal to \[=\<\] 3 follicles with a mean diameter of greater than or equal to \[\>=\] 14 millimeter \[mm\], and one or two of these follicles with a diameter of \>= 17 mm).

AS900672-Enriched 10 mcg; AS900672-Enriched 20 mcg; AS900672-Enriched 30 mcg; AS900672-Enriched 40 mcg; Follitropin alfa 75 IU

Eligibility Criteria

• Age: 18 Years - 36 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Oligo-anovulation defined by a menstrual period of 35 days to 6 months
• Spontaneous menses or a positive response to progestin within the prior 6 months or response to clomiphene citrate evidenced by ovulation within the prior 6 months
• Age between 18 and 36 years, inclusive, at time of informed consent signature
• Body mass index (BMI) 18 to 30 kilogram per square meter (kg/m\^2), inclusive
• No clinically significant abnormalities in serum thyroid stimulating hormone (TSH), dehydroepiandrosterone (DHEA-S), prolactin, and FSH levels in the early follicular phase. Subjects low TSH level who receive replacement therapy could be enrolled at the discretion of the investigator if local laboratory results (thyroxine \[T4\]) demonstrated satisfactory thyroid function. Subjects receiving stable dose of dopamine agonists could be enrolled at the discretion of the investigator if local laboratory results demonstrated adequate control of prolactin levels
• No clinically significant abnormalities in fasting glucose and fasting insulin levels
• Normal uterine cavity and presence of at least one ovary with ipsilateral patent fallopian tube, as determined by means of hysterosalpingography, laparoscopy, hysteroscopy or combination of these procedures within the prior 3 years
• Papanicolaou (PAP) smear test without clinically significant abnormalities within 6 months prior to the first screening procedure. If PAP smear is not done, it must be performed as part of screening procedures
• Negative pregnancy test prior to randomization
• Male partner with semen analysis demonstrating adequacy for insemination via intercourse and/or intrauterine insemination (IUI) within 6 months prior to the first screening procedure. If semen analysis is not done, it must be performed as part of screening procedures
• Willing and able to comply with all protocol procedures, including pregnancy and neonatal follow-up
• Voluntary provision of written informed consent, prior to any trial-related procedure that is not part of normal medical care, with the understanding that the subject could withdraw consent at any time without prejudice to her future medical care, including willingness to provide follow-up information on babies born as part of this trial

You may not qualify if:

• History of \>=2 consecutive gonadotrophin stimulation cycles that did not lead to ovulation
• History of clomiphene citrate stimulation cycles of which none lead to ovulation
• Prior excessive response to gonadotrophin stimulation, defined as the development of at least 4 mature follicles (greater than \[\>\]17 mm) or cancellation of the OI cycle due to excessive follicular response after treatment with FSH at a dose of less than 75 IU/day
• Previous severe ovarian hyperstimulation syndrome (OHSS)
• Administration of any gonadotrophin, clomiphene citrate, gonadotrophin releasing hormone (GnRH) analogue, tamoxifen or aromatase inhibitors within the prior 30 days
• Laparoscopic ovarian drilling and/or ovarian cauterization within the prior 6 months
• Any contraindication to pregnancy and/or to carrying pregnancy to term
• A clinical pregnancy that ended in a miscarriage within the prior 3 months
• History of \>=3 consecutive miscarriages, due to any cause
• Abnormal gynecological bleeding of undetermined origin
• Clinically significant abnormal findings of the uterine cavity evident on a transvaginal pelvic ultrasound performed during screening
• Presence of endometriosis, Grade III - IV or requiring treatment
• Ovarian cyst with a mean diameter of \>25 mm on the day of randomization
• History or suspicion of ovarian, uterine or mammary cancer
• Adrenal congenital hyperplasia, partial or complete enzymatic block

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead

Study Sites (1)

Merck Serono S.A.

Geneva, 1202, Switzerland

Location

MeSH Terms

Conditions

Infertility

Interventions

follitropin alfa; Follicle Stimulating Hormone; Chorionic Gonadotropin

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropins, Pituitary; Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Peptides; Amino Acids, Peptides, and Proteins; Placental Hormones; Pregnancy Proteins; Proteins

Limitations and Caveats

The study was terminated after Merck Serono had taken the decision not to pursue the development of AS900672-enriched in ovulation induction

Results Point of Contact

• Title: Merck KGaA Communication Center
• Organization: Merck Serono, a division of Merck KGaA

service@merckgroup.com

+49-6151-72-5200

Study Officials

• Antonio Pellicer, Professor Dr

  IVI Valencia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2007
• First Posted: November 5, 2007
• Study Start: December 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: February 13, 2014
• Results First Posted: July 25, 2013

Record last verified: 2014-01

Locations

CH (1)