hCG (Chorionic Gonadotropin)

Which syringe, and why

Unlike the other three compounds in this group, hCG genuinely involves a syringe, and two of them. The labelled route is intramuscular only, so the injection barrel is a 1 mL luer-lock with a detachable needle — you draw through one gauge and inject through another, and an intramuscular injection needs a needle length a fixed 1/2-inch insulin needle does not have. A second, larger syringe does the reconstitution: the powder is a lyophilised cake and the diluent volume is what sets the concentration. NOVAREL's own label tabulates the two it supports — 1 mL of diluent gives 10,000 IU/mL from the 10,000 IU vial and 5,000 IU/mL from the 5,000 IU vial, so one mark on a U-100 barrel carries 100 IU and 50 IU respectively; 10 mL of diluent gives 1,000 IU/mL from the 10,000 IU vial and 500 IU/mL from the 5,000 IU vial, so one mark on a U-100 barrel carries 10 IU and 5 IU respectively. That last figure is the one worth holding on to. Dose here is in USP units of hormone and the marks on an insulin barrel are units of volume; they are different quantities that share a word, and at 1,000 IU/mL a 500 IU dose is 0.5 mL, which is 50 marks on a U-100 barrel and not 500 of them.

Administration

1. 1

   Note which indication you are being treated under

   This is the one compound in this group with an approved male use. Both labels list, among their indications, “selected cases of hypogonadotropic hypogonadism (hypogonadism secondary to a pituitary deficiency) in males”, alongside prepubertal cryptorchidism and ovulation induction in women. Hypogonadotropic hypogonadism is secondary hypogonadism — a pituitary problem — and it is not the same thing as primary testicular failure or as using hCG to maintain testicular size on testosterone, neither of which is a labelled indication.

2. 2

   Read the label’s statement about weight loss

   It is printed in capitals at the top of the indications section on both labels, and it is there for a reason: “HCG HAS NOT BEEN DEMONSTRATED TO BE EFFECTIVE ADJUNCTIVE THERAPY IN THE TREATMENT OF OBESITY. THERE IS NO SUBSTANTIAL EVIDENCE THAT IT INCREASES WEIGHT LOSS BEYOND THAT RESULTING FROM CALORIC RESTRICTION, THAT IT CAUSES A MORE ATTRACTIVE OR ‘NORMAL’ DISTRIBUTION OF FAT, OR THAT IT DECREASES THE HUNGER AND DISCOMFORT ASSOCIATED WITH CALORIE-RESTRICTED DIETS.”

3. 3

   Reconstitute to a concentration you have chosen deliberately

   The diluent volume sets everything downstream. NOVAREL's label tabulates two: 1 mL of diluent gives 10,000 IU/mL from the 10,000 IU vial and 5,000 IU/mL from the 5,000 IU vial, so one mark on a U-100 barrel carries 100 IU and 50 IU respectively; 10 mL of diluent gives 1,000 IU/mL from the 10,000 IU vial and 500 IU/mL from the 5,000 IU vial, so one mark on a U-100 barrel carries 10 IU and 5 IU respectively. It states that the 1 mL reconstitution is for administering the entire dose at once and the 10 mL reconstitution is for “multiple dose administration, refrigerate between doses”. PREGNYL's instruction is to “remove 1 to 10 mL of solvent and add to vial with lyophilized powder; agitate gently until powder is completely dissolved in solution. Do not shake.”

4. 4

   Wipe the stoppers and inspect the solution

   NOVAREL’s label: “Remove the flip caps off the vial of bacteriostatic water and the vial of NOVAREL. Wipe the tops of the vials with an alcohol pad or alcohol soaked gauze. Do not touch the tops of the vials after you wipe them.” PREGNYL adds: “Visually inspect parenteral drug products for particulate matter and discoloration prior to administration… If there is a discoloration or particulates, do not use.”

5. 5

   Inject intramuscularly — that is the only labelled route

   PREGNYL: “For intramuscular use only. Each multiple-dose vial is to be used for one patient.” NOVAREL heads its dosage section “(Intramuscular Use Only)”. Subcutaneous hCG using an insulin syringe is extremely common in practice and is not the labelled route; it is a decision for your prescriber to make explicitly rather than something to change on your own.

6. 6

   Know your vial’s own expiry after reconstitution — the two labels differ

   PREGNYL: “IF NEEDED, THE RECONSTITUTED SOLUTION IS STABLE FOR 60 DAYS WHEN REFRIGERATED. DO NOT FREEZE. USE THE RECONSTITUTED SOLUTION WITHIN 60 DAYS OF RECONSTITUTION.” NOVAREL: “REFRIGERATE RECONSTITUTED PRODUCT AT 2° to 8°C (36° to 46°F) AND USE WITHIN 30 DAYS.” Sixty days and thirty days are both correct — for their own products, with their own diluents. Read the carton you actually have rather than the number you remember.

7. 7

   Dispose of sharps properly

   NOVAREL’s label carries its own instruction: “place used needles and syringes in a closeable, puncture-resistant container”, taken to a collection centre, and notes that “in some states, it is illegal to throw away medical sharps in household garbage, recycling, and compost bins.”

Storage

• —PREGNYL, unopened: “Store unopened vial at controlled room temperature 15°C to 25°C (59°F to 77°F).” Reconstituted: refrigerate at 2–8 °C and discard after 60 days. Do not shake. Do not freeze.
• —NOVAREL, unopened: “Store at room temperature at 20° to 25°C (68° to 77°F), excursions permitted between 15° and 30°C.” Reconstituted: refrigerate at 2–8 °C and use within 30 days.
• —Both diluents contain 0.9% benzyl alcohol as preservative. The PREGNYL solvent carries the warning that benzyl alcohol is “NOT FOR USE IN NEWBORNS”.
• —PREGNYL’s multiple-dose vial is labelled for one patient only. Sharing a vial is not a cost-saving measure; it is a contamination route.

Monitoring

Frequently asked questions

Is hCG FDA-approved for use in men?

Yes — and it is the only compound in this group of four that is. Both PREGNYL (BLA 017692, Organon) and NOVAREL (BLA 017016, Ferring) list among their indications “selected cases of hypogonadotropic hypogonadism (hypogonadism secondary to a pituitary deficiency) in males”, alongside prepubertal cryptorchidism not due to anatomical obstruction and ovulation induction in women. The AUA guideline makes the same point about the class: “Clinicians should understand that of these agents, only hCG has been approved by the FDA for use in males.”

What dose does the label state for men?

Both labels give two alternatives and frame them carefully. “The dosage regimen employed in any particular case will depend upon the indication for the use, the age and weight of the patient, and the physician’s preference. The following regimens have been advocated by various authorities.” For hypogonadotropic hypogonadism in males: “500 to 1,000 USP units 3 times a week for 3 weeks, followed by the same dose twice a week for 3 weeks”, or “4,000 USP units 3 times weekly for 6 to 9 months, following which the dosage may be reduced to 2,000 USP units 3 times weekly for an additional 3 months.” Note that these are labelled regimens for a specific diagnosis, not a general protocol for raising testosterone.

How many syringe units is 500 IU of hCG?

That depends entirely on how much diluent went into the vial, and the question is where most hCG dosing errors live — “units” means two different things in the same sentence. IU are units of hormone; the marks on a U-100 insulin barrel are units of volume, 100 of them to the millilitre. Reconstitute a 10,000 IU vial with 10 mL and you have 1,000 IU/mL, so 500 IU is 0.5 mL, which is 50 marks on a U-100 barrel. Reconstitute the same vial with 1 mL and you have 10,000 IU/mL, so 500 IU is 0.05 mL, which is 5 marks — a tenth of the volume for the same dose. The NOVAREL label tabulates both reconstitutions. Always work from the concentration on your own vial, never from a unit count someone else quoted.

Can hCG be injected subcutaneously?

Not per the label. PREGNYL states “For intramuscular use only” and NOVAREL heads its dosage section “(Intramuscular Use Only)”. Subcutaneous administration with an insulin syringe is widespread in men’s health practice and is not the labelled route for either product. That is a change of route, which is a clinical decision — ask your prescriber rather than switching on your own, and note that a fixed 1/2-inch insulin needle cannot deliver an intramuscular injection in most adults even if you intended one.

Does hCG help with weight loss?

The label answers this in capital letters, at the top of its indications section, on both products: “HCG HAS NOT BEEN DEMONSTRATED TO BE EFFECTIVE ADJUNCTIVE THERAPY IN THE TREATMENT OF OBESITY. THERE IS NO SUBSTANTIAL EVIDENCE THAT IT INCREASES WEIGHT LOSS BEYOND THAT RESULTING FROM CALORIC RESTRICTION, THAT IT CAUSES A MORE ATTRACTIVE OR ‘NORMAL’ DISTRIBUTION OF FAT, OR THAT IT DECREASES THE HUNGER AND DISCOMFORT ASSOCIATED WITH CALORIE-RESTRICTED DIETS.” It is unusual for a label to say something that bluntly, and the reason is that hCG diet products have been marketed for decades against it.

How long does a reconstituted vial last?

It depends which product you have, and the two approved labels genuinely differ. PREGNYL states that the reconstituted solution “is stable for 60 days when refrigerated” and to use it within 60 days of reconstitution. NOVAREL states “REFRIGERATE RECONSTITUTED PRODUCT AT 2° to 8°C (36° to 46°F) AND USE WITHIN 30 DAYS.” Both are correct for their own product and diluent — PREGNYL ships its own buffered solvent, NOVAREL is reconstituted with Bacteriostatic Water for Injection. This page does not average them or pick a side; read the carton in front of you.

Sources

1. [1]FDA label — PREGNYL (chorionic gonadotropin) for injection, Organon LLC (DailyMed SPL 1e94155f-19be-4944-b197-be4edbb4faf9; marketing category BLA 017692). Source of the male hypogonadotropic hypogonadism indication, the two male regimens, the obesity statement, “For intramuscular use only”, the reconstitution directions and the 60-day refrigerated stability
2. [2]FDA label — NOVAREL (chorionic gonadotropin) for injection, for intramuscular use, Ferring Pharmaceuticals Inc. (DailyMed SPL ac6918ff-9dc3-40d9-8619-54b26e4bdfc8; marketing category BLA 017016, initial US approval 1974). Source of the reconstitution concentration table (1 mL and 10 mL of bacteriostatic water), the contraindications including prostatic carcinoma, the sharps disposal instruction and the 30-day refrigerated limit
3. [3]Mulhall JP, Trost LW, Brannigan RE, et al. Evaluation and Management of Testosterone Deficiency: AUA Guideline. J Urol. 2018;200(2):423–432 (PMID 29601923). Statement 27 and its discussion — the source of both quoted sentences, including “Clinicians should understand that of these agents, only hCG has been approved by the FDA for use in males.”
4. [4]Drugs@FDA: FDA-Approved Drugs — used to confirm that both chorionic gonadotropin products are licensed biologics (BLA 017692 and BLA 017016) rather than unapproved or compounded preparations

Related

• Testosterone cypionate — the labelled comparator
• TRT — how it works and what it costs
• Compare online TRT providers
• Peptide reconstitution calculator
• Insulin syringe conversion chart
• Clomiphene — off-label in men