Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Indian Women

NCT04773353 | Completed Phase 3

• 1 other identifier: 000320
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 12

Brief Summary

To demonstrate non-inferiority of FE 999049 compared with GONAL-F with respect to ongoing pregnancy rate in women undergoing controlled ovarian stimulation.

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• Ongoing pregnancy rate

  Ongoing pregnancy is defined as at least one intrauterine viable fetus 10-11 weeks after embryo transfer.

  10-11 weeks after embryo transfer

Secondary Outcomes (54)

• Positive beta human chorionic gonadotropin (βhCG) rate

  13-15 days after embryo transfer

• Clinical pregnancy rate

  5-6 weeks after embryo transfer

• Vital pregnancy rate

  5-6 weeks after embryo transfer

• Implantation rate

  5-6 weeks after embryo transfer

• Ongoing implantation rate

  10-11 weeks after embryo transfer

Study Arms (2)

Follitropin Delta (FE 999049)

EXPERIMENTAL

Recombinant follicle-stimulating hormone (rFSH). Follitropin delta for subcutaneous injection

Drug: Follitropin Delta (FE 999049)

Follitropin Alfa (GONAL-F)

EXPERIMENTAL

rFSH. Follitropin alfa for subcutaneous injection

Drug: Follitropin Alfa (GONAL-F)

Interventions

Follitropin Delta (FE 999049) DRUG

FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their anti-Müllerian hormone (AMH) level at screening and their body weight at randomization. For participants with low AMH (\<15 pmol/L) the daily FE 999049 dose was 12 μg, irrespective of body weight. For participants with high AMH (≥15 pmol/L) the daily FE 999049 dose was on a continuous scale ranging from 0.19 to 0.10 μg/kg, i.e. dependent on actual AMH and body weight. The daily FE 999049 dose was fixed throughout the stimulation period and maximum allowed daily dose was 12 μg. Participants could be treated for a maximum of 20 days.

Also known as: REKOVELLE

Follitropin Delta (FE 999049)

Follitropin Alfa (GONAL-F) DRUG

GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Participants could be treated for a maximum of 20 days.

Also known as: GONAL-F

Follitropin Alfa (GONAL-F)

Eligibility Criteria

• Age: 21 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Informed Consent Forms signed prior to screening evaluations.
• In good physical and mental health as judged by the investigator.
• Indian (i.e., possessing an Indian identification card and having native Indian parents) pre-menopausal females between the ages of 21 and 40 years. The participants must be at least 21 years (including the 21st birthday) when they sign the informed consent and no more than 40 years (up to the day before the 41st birthday) at the time of randomization.
• Infertile women diagnosed with tubal infertility, unexplained infertility, endometriosis stage I/II (defined by the revised American Society for Reproductive Medicine \[ASRM\] classification, 1996) or with partners diagnosed with male factor infertility, eligible for in vitro fertilization (IVF) and/or ICSI using fresh or frozen ejaculated sperm from male partner or sperm donor.
• Infertility for at least one year before randomization for participants \<35 years or for at least 6 months for participants ≥35 years (not applicable in case of tubal or severe male factor infertility).
• The trial cycle will be the participant's first controlled ovarian stimulation cycle for IVF/ICSI.
• Regular menstrual cycles of 24-35 days (both inclusive), presumed to be ovulatory.
• Hysterosalpingography, hysteroscopy, saline infusion sonography, or transvaginal ultrasound documenting a uterus consistent with expected normal function (e.g. no evidence of clinically interfering uterine fibroids defined as submucous or intramural fibroids larger than 3 cm in diameter, no polyps and no congenital structural abnormalities which are associated with a reduced chance of pregnancy) within 1 year prior to randomization.
• Transvaginal ultrasound documenting presence and adequate visualization of both ovaries, without evidence of significant abnormality (e.g., enlarged ovaries which would contraindicate the use of gonadotropins) and normal adnexa (e.g., no hydrosalpinx) within 1 year prior to randomization. Both ovaries must be accessible for oocyte retrieval.
• Early follicular phase (cycle day 2-4) serum levels of FSH between 1 and 15 IU/L (results obtained within 3 months prior to randomization).
• Negative serum Hepatitis B Surface Antigen (HBsAg), Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) antibody tests within 1 year prior to randomization.
• Body mass index (BMI) between 17.5 and 32.0 kg/m\^2 (both inclusive) at screening.
• Willing to accept transfer of 1-2 embryos.

You may not qualify if:

• Known endometriosis stage III-IV (defined by the revised ASRM classification, 1996).
• One or more follicles ≥10 mm (including cysts) observed on the transvaginal ultrasound prior to randomization on stimulation day 1 (puncture of cysts is allowed prior to randomization).
• Known history of recurrent miscarriage (defined as three consecutive losses after ultrasound confirmation of pregnancy \[excluding ectopic pregnancy\] and before Week 24 of pregnancy).
• Known abnormal karyotype of participant or of her partner/sperm donor, as applicable, depending on source of sperm used for insemination in this trial.
• Any known clinically significant systemic disease (e.g., insulin-dependent diabetes).
• Known inherited or acquired thrombophilia disease.
• Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events.
• Known porphyria.
• Any known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney) with the exception of controlled thyroid function disease.
• Known presence of anti-FSH antibodies (based on the information available in the participant's medical records).
• Known tumors of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus which would contraindicate the use of gonadotropins.
• Known moderate or severe impairment of renal or hepatic function.
• Any abnormal finding of clinical chemistry, haematology or vital signs at screening which is clinically significant as judged by the investigator.
• Currently breast-feeding.
• Undiagnosed vaginal bleeding.

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (12)

Ferring Investigational Site

Ahmedabad, Gujarat, India

Location

Ferring Investigational Site

Anand, Gujarat, India

Location

Ferring Investigational Site

Nashik, Maharashtra, India

Location

Ferring Investigational Site

Pune, Mumbai, India

Location

Ferring Investigational Site

Varanasi, New Delhi, India

Location

Ferring Investigational Site

Chennai, Tamil Nadu, India

Location

Ferring Investigational Site

Coimbatore, Tamil Nadu, India

Location

Ferring Investigational Site

Secunderabad, Telangana, India

Location

Ferring Investigational Site

Lucknow, Uttar Pradesh, India

Location

Ferring Investigational Site

Bangalore, India

Location

Ferring Investigational Site

Kolhāpur, India

Location

Ferring Investigational Site

New Delhi, India

Location

MeSH Terms

Conditions

Infertility

Interventions

follitropin delta; FE 999049; follitropin alfa

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Global Clinical Compliance

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 26, 2021
• Study Start: December 3, 2021
• Primary Completion: December 12, 2023
• Study Completion: December 12, 2023
• Last Updated: January 24, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IN (12)