Phase 3
N=31
A Study Using Recombinant Human Luteinizing Hormone (r-hLH, Luveris®) in the Treatment of Chinese Women With Hypogonadotropic Hypogonadism
Hypogonadism
Bottom Line
View on ClinicalTrials.gov: NCT01084265 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
May 2012
Primary outcome: Primary: Number of Participants Who Met Both Index 1 and Index 2 — 23 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Recombinant human luteinizing hormone (r-hLH) (Drug); Recombinant human follicle-stimulating hormone (r-hFSH) (Drug); Human chorionic gonadotropin (hCG) (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- Merck KGaA, Darmstadt, Germany
- Primary completion
- Dec 2005
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Met Both Index 1 and Index 2 |
23 | — |
| PRIMARY Number of Participants Who Had at Least One Follicle Greater Than 17mm in Diameter |
23 | — |
| PRIMARY Number of Participants With E2 Level in Blood Serum Above 109 pg/mL on the Day of hCG Injection |
23 | — |
| PRIMARY Number of Participants Who Refused to Take hCG Injection |
0; 10 | — |
| SECONDARY Mean Number of Follicles With Diameter in the Range of 10-17 mm on the Day of hCG Injection in Treatment Cycle |
3.57 | — |
| SECONDARY Mean Number of Follicles With the Diameter Above 17 mm on the Day of hCG Injection in Treatment Cycle |
2.13 | — |
| SECONDARY Average Change of E2 Level in Participants Per Day up to Day 14 |
71.03 | — |
| SECONDARY Number of Participants With Confirmed Pregnancies: Biochemical Pregnancies and Clinical Pregnancies |
1; 9 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
0; 0 | — |
Summary
This was a prospective, open, non-comparative study to evaluate the safety and efficacy of recombinant human luteinizing hormone (rhLH, Luveris) administered subcutaneously (s.c.) in follicular development during ovulation induction in 31 Chinese female subjects with hypogonadotropic hypogonadism.
Eligibility Criteria
Inclusion Criteria
- Be premenopausal, between 18 and 39 years of age
- Have a clinical history of hypogonadotropic hypogonadism, and laboratory test result comply with diagnosis of hypogonadotropic hypogonadism during screening procedure
- Have discontinued gonadotropins, gonadotropin-releasing hormone (GnRH) (gonadotropin naïve), or estrogen progesterone replacement therapy at least one month before the screening procedure
- Have a negative progestin challenge test performed during screening
- Have the following hormonal values in a centrally analyzed fasting blood sample, drawn within 6 months before initiation of treatment:
- Follicular stimulating hormone (FSH): < 5 international units/liter (IU/L)
- Luteinizing hormone (LH): < 1.2 IU/L
- Oestradiol (E2): < 60 picogram/milliliter (pg/mL) (<220 picomolar/liter [pmol/L])
- Prolactin (PRL): < 44.3 nanogram/milliliter (ng/mL) (< 1040 milli-international units/liter [mIU/L])
- Thyrotrophin-stimulating hormone (TSH): < 6.5 micro-international units (uIU/mL)
- Free Thyroxine (T4): 0.8-1.8 nanogram/deciliter (ng/dL) (11-24 pmol/L)
- Triiodothyronine (T3): < 1.0 ng/mL (< 3.5 nanomolar/liter [nmol/L])
- Have an endovaginal pelvic ultrasound scan showing (i) no ovarian tumor and cyst < 2 centimeters (cm); (ii) no clinically significant uterine abnormality, and (iii) < 13 mm small follicles (mean diameter < 10 mm) on the largest section through each ovary
- Have a normal cervical pap smear within 6 months of the initial visit
- Have a body mass index (BMI) between 18.4 and 31.4 kilogram/meter square (kg/m^2)
- Be willing and able to comply with the protocol for the duration of the study
- Have given written informed consent prior to any study related procedure
Exclusion Criteria
- Ongoing pregnancy
- Any chronic systemic disease
- Hypersensitive to study drug and control drug
- History of severe ovarian hyperstimulation syndrome
- Abnormal gynecological bleeding of undetermined origin
- Previous or current hormone dependent tumor
- Known active substance abuse or eating disorder
- Known central nervous system (CNS) lesions: In cases where hypogonadotropic hypogonadism (HH) is secondary to a CNS lesion or its treatment, the subject will not be eligible without consulting Serono's Medical Director
- Exercise program exceeding 10 hours per week
- Currently undergoing treatment with psychotropic medication or with any other medication known to interfere with normal reproductive function (for example, neuroleptics, dopamine antagonists)
- There is any abnormality, decided by investigators, which might produce effect on the absorption, distribution and excretion of investigational drug
Data sourced from ClinicalTrials.gov (NCT01084265). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.