Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Pan-Asian Women

A Randomised, Controlled, Assessor-blind, Parallel Groups, Multicentre, Pan-Asian Trial Comparing the Efficacy and Safety of FE 999049 With Follitropin Alfa (GONAL-F) in Controlled Ovarian Stimulation in Women Undergoing Assisted Reproductive Technology Programme

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

Study Overview

• Status: Completed
• Conditions: Controlled Ovarian Simulation
• Intervention / Treatment: Drug: Follitropin delta; Drug: Follitropin alfa

• Study Type: Interventional
• Enrollment (Actual): 1011
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking University First Hospital
  • Beijing, China
    • Beijing Obstetrics and Gynecology Hospital,Capital Medical University
  • Beijing, China
    • Medical Center for Human Reproduction, Peking University Third Hospital
  • Chengdu, China
    • West China Second University Hospital of Sichuan University
  • Guangzhou, China
    • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
  • Guangzhou, China
    • The Sixth Affiliated Hospital of Sun Yat-sen University
  • Guangzhou, China
    • The Third Affiliated Hospital of Guangzhou Medical University
  • Hefei, China
    • The First Affiliated Hospital of An'hui Medical University
  • Nanjing, China
    • Jiangsu Province Hospital
  • Shenyang, China
    • Shengjing Hospital of China Medical University
  • Shenzhen, China
    • Peking University Shenzhen Hospital
  • Tianjin, China
    • Tianjin Medical University General Hospital
  • Tianjin, China
    • Tianjin Central Hospital of Gynaecology and Obstetrics
  • Wuhan, China
    • Renmin Hospital of Wuhan University
  • Wuhan, China
    • Tongji Hospital,Tongji Medical College, Huazhong University of Science & Technology
  • Zhengzhou, China
    • The First Affiliated Hospital of Zhengzhou University
• Korea, Republic of
  • Seongnam-si, Korea, Republic of
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
  • Seoul, Korea, Republic of
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • Samsung Medical Center
• Taiwan
  • Taichung, Taiwan
    • Taichung Veterans General Hospital
  • Taipei, Taiwan
    • National Taiwan University Hospital
  • Taipei, Taiwan
    • Taipei Medical University Hospital
  • Taoyuan, Taiwan
    • Chang Gung Memorial Hospital
• Vietnam
  • Hanoi, Vietnam
    • National Center for Assisted Reproductive Technology
  • Ho Chi Minh City, Vietnam
    • My Duc Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Informed Consent Documents signed prior to screening evaluations.
• In good physical and mental health in the judgement of the investigator.
• Asian pre-menopausal females between the ages of 20 and 40 years. The participants must be at least 20 years (including the 20th 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 fertilisation (IVF) and/or intracytoplasmic sperm injection (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 visualisation 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 2 years prior to randomization.
• Body mass index (BMI) between 17.5 and 32.0 kg/m2 (both inclusive) at screening.
• Willing to accept transfer of 1-2 embryos.

Exclusion Criteria:

• 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 (excl. 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; i.e. not based on the anti-FSH antibody analyses conducted in the trial).
• Known tumours 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.
• Known abnormal cervical cytology of clinical significance observed within three years prior to randomization (unless the clinical significance has been resolved).
• Findings at the gynaecological examination at screening which preclude gonadotropin stimulation or are associated with a reduced chance of pregnancy, e.g. congenital uterine abnormalities or retained intrauterine device.
• Pregnancy (negative urinary pregnancy tests must be documented at screening and prior to randomization) or contraindication to pregnancy.
• Known current active pelvic inflammatory disease.
• Use of fertility modifiers during the last menstrual cycle before randomization, including dehydroepiandrosterone (DHEA), metformin or cycle programming with oral contraceptives, progestogen or estrogen preparations.
• Use of hormonal preparations (except for thyroid medication) during the last menstrual cycle before randomization.
• Known history of chemotherapy (except for gestational conditions) or radiotherapy.
• Current or past (1 year prior to randomization) abuse of alcohol or drugs.
• Current (last month) intake of more than 14 units of alcohol per week.
• Current or past (3 months prior to randomization) smoking habit of more than 10 cigarettes per day.
• Hypersensitivity to any active ingredient or excipients in the medicinal products used in the trial.
• Previous participation in the trial.
• Use of any non-registered investigational drugs during the last 3 months prior to randomization.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Follitropin delta; Recombinant follicle-stimulating hormone (rFSH). Follitropin delta for subcutaneous injection	Drug: Follitropin delta; REKOVELLE (FE 999049) was fixed throughout the stimulation period.; Other Names: FE 999049; REKOVELLE
Active Comparator: Gonal-F; rFSH. Follitropin alfa for subcutaneous injection	Drug: Follitropin alfa; GONAL-F dose was fixed for the first 5 stimulation days.; Other Names: GONAL-F

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ongoing Pregnancy Rate	Defined as at least one intrauterine viable fetus 10-11 weeks after transfer.	10-11 weeks after transfer

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive Beta Unit of Human Chorionic Gonadotropin (βhCG) Rate	Defined as positive βhCG test 13-15 days after transfer.	13-15 days after transfer
Clinical Pregnancy Rate	Defined as at least one gestational sac 5-6 weeks after transfer.	5-6 weeks after transfer
Vital Pregnancy Rate	Defined as at least one intrauterine gestational sac with fetal heart beat 5-6 weeks after transfer.	5-6 weeks after transfer
Implantation Rate	Defined as number of gestational sacs 5-6 weeks after transfer divided by number of embryos transferred.	5-6 weeks after transfer
Ongoing Implantation Rate	Defined as number of intrauterine viable fetuses 10-11 weeks after transfer divided by number of embryos transferred.	10-11 weeks after transfer
Proportion of Subjects With Early OHSS (Including OHSS of Moderate/Severe Grade) and/or Preventive Interventions for Early OHSS	Early OHSS was defined as OHSS with onset ≤9 days after triggering of final follicular maturation. Classification of grade was according to Golan's classification system, and all OHSS cases were graded as mild, moderate or severe.	Up to 9 days after triggering of final follicular maturation
Number of Oocytes Retrieved	The number of oocytes retrieved was recorded at the oocyte retrieval visit.	On the day of oocyte retrieval (36 h [±2h] after triggering of final follicular maturation)
Fertilization Rate	The fertilization rate was defined as the number of oocytes with 2 pronuclei divided by the number of oocytes retrieved.	On Day 1 after oocyte retrieval
Number and Quality of Embryos	Number of embryos (total and good-quality) on Day 3 are presented. A good-quality embryo was defined as an embryo with ≥6 blastomeres and ≤20% fragmentation, without signs of multinucleation.	On Day 3 after oocyte retrieval
Circulating Concentrations of Luteinizing Hormone (LH)	Blood samples for analysis of circulating concentrations of LH were drawn. The median and inter-quartile range (IQR) of LH levels on stimulation Day 6 are presented.	On stimulation Day 6
Circulating Concentrations of LH	Blood samples for analysis of circulating concentrations of LH were drawn. The median and IQR of LH levels at end-of-stimulation are presented.	End-of-stimulation (up to 20 stimulation days)
Circulating Concentrations of Estradiol	Blood samples for analysis of circulating concentrations of estradiol were drawn. The median and IQR of estradiol levels on stimulation Day 6 are presented.	On stimulation Day 6
Circulating Concentrations of Estradiol	Blood samples for analysis of circulating concentrations of estradiol were drawn. The median and IQR of estradiol levels at end-of-stimulation are presented.	End-of-stimulation (up to 20 stimulation days)
Circulating Concentrations of Progesterone	Blood samples for analysis of circulating concentrations of progesterone were drawn. The median and IQR of progesterone levels on stimulation Day 6 are presented.	On stimulation Day 6
Circulating Concentrations of Progesterone	Blood samples for analysis of circulating concentrations of progesterone were drawn. The median and IQR of progesterone levels at end-of-stimulation are presented.	End-of-stimulation (up to 20 stimulation days)
Circulating Concentrations of Inhibin A	Blood samples for analysis of circulating concentrations of inhibin A. The median and IQR of inhibin A levels on stimulation Day 6 are presented.	On stimulation Day 6
Circulating Concentrations of Inhibin A	Blood samples for analysis of circulating concentrations of inhibin A were drawn. The median and IQR of inhibin A levels at end-of-stimulation are presented.	End-of-stimulation (up to 20 stimulation days)
Circulating Concentrations of Inhibin B	Blood samples for analysis of circulating concentrations of Inhibin B were drawn. The median and IQR of inhibin B levels on stimulation Day 6 are presented.	On stimulation Day 6
Circulating Concentrations of Inhibin B	Blood samples for analysis of circulating concentrations of Inhibin B were drawn. The median and IQR of inhibin B levels at end-of-stimulation are presented.	End-of-stimulation (up to 20 stimulation days)
Circulating Concentrations of Follicle-stimulating Hormone (FSH)	Blood samples for analysis of circulating concentrations of FSH were drawn. The median and IQR of FSH levels on stimulation Day 6 are presented.	On stimulation Day 6
Circulating Concentrations of FSH	Blood samples for analysis of circulating concentrations of FSH were drawn. The median and IQR of FSH levels at end-of-stimulation are presented.	End-of-stimulation (up to 20 stimulation days)
Circulating Concentrations of FSH	Blood samples for analysis of circulating concentrations of FSH were drawn. The median and IQR of FSH levels at oocyte retrieval are presented.	At oocyte retrieval
Total Gonadotropin Dose	Calculated by start dates, end dates and daily dose of IMP.	Up to 20 stimulation days
Proportion of Subjects With Investigator-requested Gonadotropin Dose Adjustments	Investigator-requested decreases and increases of the gonadotropin dose were captured during the stimulation period.	Up to 20 stimulation days
Number of Stimulation Days	Calculated by start dates and end dates.	Up to 20 stimulation days
Intensity of Adverse Events	The intensity of adverse event was classified using the following 3-point scale: mild = awareness of signs or symptoms, but no disruption of usual activity; moderate = event sufficient to affect usual activity (disturbing); or severe = inability to work or perform usual activities (unacceptable).	From screening up to end-of-trial (up to approximately 5.5 months)
Changes From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase and Gamma Glutamyl Transferase	Blood samples were collected for the analysis of clinical chemistry parameters including: Alanine aminotransferase, Alkaline phosphatase, Aspartate aminotransferase and Gamma glutamyl transferase.	From screening up to end-of-trial (up to approximately 5.5 months)
Change From Baseline in Clinical Chemistry Parameters: Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Phosphate, Potassium and Sodium	Blood samples were collected for the analysis of clinical chemistry parameters including: Bicarbonate, Blood urea nitrogen, Calcium, Chloride, Cholesterol, Glucose, Phosphate, Potassium and Sodium.	From screening up to end-of-trial (approximately 5.5 months)
Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein	Blood samples were collected for the analysis of clinical chemistry parameters including: Albumin and Protein.	From screening up to end-of-trial (approximately 5.5 months)
Change From Baseline in Clinical Chemistry Parameter: Lactate Dehydrogenase	Blood samples were collected for the analysis of clinical chemistry parameter including: Lactate dehydrogenase.	From screening up to end-of-trial (approximately 5.5 months)
Change From Baseline in Clinical Chemistry Parameter: Direct Bilirubin, Bilirubin, Creatinine, Urate	Blood samples were collected for the analysis of clinical chemistry parameter including: Direct bilirubin, Bilirubin, Creatinine, Urate.	From screening up to end-of-trial (approximately 5.5 months)
Change From Baseline in Haematology Parameter: Erythrocytes	Blood samples were collected for the analysis of haematology parameter including: Erythrocytes.	From screening up to end-of-trial (approximately 5.5 months)
Change From Baseline in Haematology Parameters: Leukocytes and Platelets	Blood samples were collected for the analysis of haematology parameters including: Leukocytes and Platelets.	From screening up to end-of-trial (approximately 5.5 months)
Change From Baseline in Haematology Parameter: Haemoglobin	Blood samples were collected for the analysis of haematology parameter including: Haemoglobin.	From screening up to end-of-trial (approximately 5.5 months)
Change From Baseline in Haematology Parameter: Haematocrit	Blood samples were collected for the analysis of haematology parameter including: Haematocrit.	From screening up to end-of-trial (approximately 5.5 months)
Change From Baseline in Haematology Parameter: Erythrocyte Mean Corpuscular Volume	Blood samples were collected for the analysis of haematology parameter including: Erythrocyte mean corpuscular volume.	From screening up to end-of-trial (approximately 5.5 months)
Change From Baseline in Haematology Parameter: Erythrocyte Mean Corpuscular Haemoglobin	Blood samples were collected for the analysis of haematology parameter including: Erythrocyte mean corpuscular haemoglobin.	From screening up to end-of-trial (approximately 5.5 months)
Change From Baseline in Haematology Parameter: Erythrocyte Mean Corpuscular Haemoglobin Concentration	Blood samples were collected for the analysis of haematology parameter including: Erythrocyte mean corpuscular haemoglobin concentration.	From screening up to end-of-trial (approximately 5.5 months)
Change From Baseline in Haematology Parameters: Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes and Neutrophils/Leukocytes	Blood samples were collected for the analysis of haematology parameters including: Basophils/leukocytes, Eosinophils/leukocytes, Lymphocytes/leukocytes, Monocytes/leukocytes and Neutrophils/leukocytes.	From screening up to end-of-trial (approximately 5.5 months)
Number of Immune-related Adverse Events	Standardised Medical Dictionary for Regulatory Activities (MedDRA) Queries (SMQs).	From screening up to end-of-trial (approximately 5.5 months)
Proportion of Subjects With Treatment-induced Anti-FSH Antibodies, Overall as Well as With Neutralizing Capacity	Measured by presence of anti-FSH antibodies.	Up to 28 days after end of the stimulation period
Intensity of Immune-related Adverse Events	The intensity of immune-related adverse event was classified using the following 3-point scale: mild = awareness of signs or symptoms, but no disruption of usual activity; moderate = event sufficient to affect usual activity (disturbing); or severe = inability to work or perform usual activities (unacceptable).	From screening up to end-of-trial (approximately 5.5 months)
Proportion of Subjects With Late OHSS	Late OHSS was defined as OHSS with onset >9 days after triggering of final follicular maturation. The proportion of participants with late OHSS, and late OHSS of moderate or severe grade are presented. All OHSS cases were graded as mild, moderate, or severe.	After 9 days post triggering of final follicular maturation
Proportion of Subjects With Extreme Ovarian Responses	Extreme ovarian response defined as <4, ≥15 or ≥ 20 oocytes retrieved. Participants with cycle cancellation due to poor ovarian response are included as <4 oocytes retrieved.	Oocyte retrieval visit
Proportion of Subjects With Cycle Cancellation Due to Poor or Excessive Ovarian Response or Embryo Transfer Cancellation Due to Excessive Ovarian Response / OHSS Risk	For each participant the reason for each cycle cancellation was recorded. Embryo transfer cancellation due to adverse events, such as ovarian hyperfunction, OHSS and progesterone increased in participants with embryos available for transfer, were considered as transfer cancellations due to excessive response / OHSS risk.	End-of-stimulation visit (up to 20 days) or transfer visit
Number of Follicles on Stimulation Day 6	Counted by ultrasound for the right and left ovary for each participant.	On stimulation Day 6
Number of Follicles At End-of-stimulation (up to 20 Stimulation Days)	Counted by ultrasound for the right and left ovary for each participant.	At end-of-stimulation (up to 20 stimulation days)
Size of Follicles on Stimulation Day 6	Counted by ultrasound for the right and left ovary for each participant.	On stimulation Day 6
Size of Follicles At End-of-stimulation (up to 20 Stimulation Days)	Counted by ultrasound for the right and left ovary for each participant.	At end-of-stimulation (up to 20 stimulation days)
Proportion of Subjects With <4, 4-7, 8-14, 15-19 and ≥20 Oocytes Retrieved	Grouped according to the number of oocytes retrieved. Participants with cycle cancellation due to poor ovarian response are included in the <4 oocytes group.	On the day of oocyte retrieval
Percentage of Metaphase II (MII) Oocytes	The percentage of MII oocytes to oocytes retrieved for participants where all oocytes were inseminated using intracytoplasmic sperm injection (ICSI) are presented.	Prior to insemination
Number of Participants With Adverse Events	Any adverse event occurring after start of IMP and before the end-of-trial visit, or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and before the end-of-trial visit was considered treatment-emergent, and is presented for this endpoint.	From screening up to end-of-trial (up to approximately 5.5 months)
Proportion of Subjects With Markedly Abnormal Changes of Clinical Chemistry: Alanine Aminotransferase, Aspartate Aminotransferase, Bicarbonate, Calcium, Phosphate	The table represents the percentage of participants in each group with normal baseline values and markedly abnormal end-of-stimulation or end-of-trial values for alanine aminotransferase, aspartate aminotransferase, bicarbonate, calcium, phosphate.	End-of-stimulation visit and end-of-trial visit
Proportion of Subjects With Markedly Abnormal Changes of Haematology Parameters: Leukocytes, Lymphocytes/Leukocytes	The table represents the percentage of participants in each group with normal baseline values and markedly abnormal end-of-stimulation and end-of-trial values for leukocytes and lymphocytes/leukocytes.	End-of-stimulation visit and end-of-trial visit
Frequency of Injection Site Reactions	Assessed by the participant during the stimulation period. Participants assessed the injection site reactions (redness, pain, itching, swelling and bruising) three times daily: immediately after the injection, 30 minutes after the injection and 24 hours after the injection.	End-of-stimulation (up to 20 stimulation days)
Intensity of Injection Site Reactions	Assessed by the participant during the stimulation period as mild, moderate or severe. Participants are tabulated according to the highest severity of their reported injection site reactions.	End-of-stimulation (up to 20 stimulation days)
Proportion of Subjects With Cycle Cancellations Due to an Adverse Event, Including Immune-related Adverse Events, or Due to Technical Malfunctions of the Administration Pen	For each participant the reason for cycle cancellation will be recorded.	Up to 20 stimulation days
Proportion of Participants With Multi-fetal Gestation	Defined as pregnancy with more than one fetus. Among participants with ongoing pregnancy, percentage of participants with twin pregnancies are presented.	End-of-trial
Proportion of Participants With Early Pregnancy Losses	Grouped according to occurrence of biochemical pregnancy, spontaneous abortion, vanishing twin or ectopic pregnancy (with and without medical/surgical intervention). Frequency of early pregnancy losses are presented.	End-of-trial
Proportion of Participants With Technical Malfunctions of the Administration Pen	Incidences of technical malfunctions of the administration pen were recorded.	End-of-stimulation (up to 20 stimulation days)

Collaborators and Investigators

• Sponsor: Ferring Pharmaceuticals
• Investigators: Study Director: Global Clinical Compliance, Ferring Pharmaceuticals

Publications and helpful links

General Publications

• Qiao J, Zhang Y, Liang X, Ho T, Huang HY, Kim SH, Goethberg M, Mannaerts B, Arce JC. A randomised controlled trial to clinically validate follitropin delta in its individualised dosing regimen for ovarian stimulation in Asian IVF/ICSI patients. Hum Reprod. 2021 Aug 18;36(9):2452-2462. doi: 10.1093/humrep/deab155.
• Yang R, Zhang Y, Liang X, Song X, Wei Z, Liu J, Yang Y, Tan J, Zhang Q, Sun Y, Wang W, Qian W, Jin L, Wang S, Xu Y, Yang J, Goethberg M, Mannaerts B, Wu W, Zheng Z, Qiao J. Comparative clinical outcome following individualized follitropin delta dosing in Chinese women undergoing ovarian stimulation for in vitro fertilization /intracytoplasmic sperm injection. Reprod Biol Endocrinol. 2022 Oct 4;20(1):147. doi: 10.1186/s12958-022-01016-y.
• Fernandez-Sanchez M, Fatemi H, Garcia-Velasco JA, Heiser PW, Daftary GS, Mannaerts B. Incidence and severity of ovarian hyperstimulation syndrome (OHSS) in high responders after gonadotropin-releasing hormone (GnRH) agonist trigger in "freeze-all" approach. Gynecol Endocrinol. 2023 Dec;39(1):2205952. doi: 10.1080/09513590.2023.2205952.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): January 3, 2020
• Study Completion (Actual): July 26, 2020

Study Registration Dates

• First Submitted: September 14, 2017
• First Submitted That Met QC Criteria: September 25, 2017
• First Posted (Actual): September 28, 2017

Study Record Updates

• Last Update Posted (Actual): August 24, 2023
• Last Update Submitted That Met QC Criteria: August 9, 2023
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Follicle Stimulating Hormone
• Other Study ID Numbers: 000145

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No