1 What is this medicine
and what is it used for?
Progesterone 8% vaginal gel delivers natural micronised
progesterone directly to the uterus via vaginal absorption. Progesterone is the
key hormone required to prepare the uterine lining (endometrium) for embryo
implantation and to maintain early pregnancy by suppressing uterine
contractions, thickening the endometrium, and supporting placental development
in early gestation.
It is used for:
• Luteal phase support in women
undergoing assisted reproductive technology (ART) — including in vitro
fertilisation (IVF) and frozen embryo transfer (FET) cycles, to supplement the
progesterone normally produced by the corpus luteum.
• Prevention of preterm birth in women
with a short cervix (cervical length < 25 mm on transvaginal ultrasound at
16–24 weeks) — as part of a cervical incompetence management programme.
• Treatment of threatened miscarriage
or recurrent miscarriage — in some protocols, based on clinical evidence.
2 How to use this
medicine
Insert one applicator vaginally once daily (evening
application is usually recommended for ART support) or as prescribed. The
pre-filled applicator is used by lying on your back with knees bent, inserting
the applicator into the vagina and pressing the plunger. The bioadhesive gel
adheres to the vaginal wall and releases progesterone slowly.
|
Insert at bedtime to
reduce leakage. A thin liner may be used for comfort. Do not use tampons —
they will absorb the gel. Continue using even
after confirmed pregnancy — stopping suddenly before your doctor advises can
increase miscarriage risk. A white gel residue
may accumulate in the vagina — this is normal and not a sign of infection. |
3 Possible side effects
|
Frequency |
Side Effect |
What to Do |
|
Very Common (>10%) |
Vaginal discharge /
gel residue |
Normal bioadhesive gel
accumulation. Panty liner for comfort. Harmless. |
|
Very Common (>10%) |
Somnolence / fatigue |
Progesterone has mild
sedative properties. Evening dosing helps. |
|
Common (1–10%) |
Headache |
Paracetamol if needed.
Usually mild. |
|
Common (1–10%) |
Breast tenderness |
Supportive bra;
usually settles as body adjusts to progesterone. |
|
Common (1–10%) |
Nausea |
Take in the evening;
usually mild. |
|
Common (1–10%) |
Abdominal bloating /
cramping |
Usually mild; ensure
continued use unless severe. |
|
Common (1–10%) |
Mood changes
(depression, irritability) |
Report significant
mood changes to your doctor. |
|
Uncommon |
Vaginal irritation or
itching |
Consult your doctor if
significant; may require assessment for concurrent infection. |
4 Who should not use this
medicine
|
Do NOT use Progesterone 8% Gel if: You have undiagnosed
vaginal bleeding. You have a known or
suspected hormone-sensitive malignancy (breast cancer, endometrial cancer)
unless prescribed by a specialist. You have active
thromboembolic disease (deep vein thrombosis, pulmonary embolism). You have severe
hepatic impairment. You have a known
allergy to progesterone, palm oil, or any gel excipient. You have ectopic
pregnancy (unruptured) — progesterone may support an ectopic pregnancy. |
5 Drug interactions
• Oral progesterone / other
progestogens: avoid duplication — do not use simultaneously with other
progesterone formulations unless specifically directed.
• Enzyme inducers (rifampicin,
carbamazepine, St John's Wort): may reduce progesterone levels — specialist
guidance required.
• Ciclosporin: progesterone may inhibit
ciclosporin metabolism — monitor levels.
6 Storage
Store at room temperature below 25°C. Do not refrigerate or
freeze. Keep away from direct sunlight. Keep out of reach of children. Each
applicator is for single use — do not reuse. Return unused applicators to the
pharmacy.
7 Prescription
requirement
|
PRESCRIPTION ONLY
MEDICINE (POM) — Prescribed by a gynaecologist, reproductive endocrinologist,
or fertility specialist. Duration of use and
timing are determined by the specific ART protocol or clinical indication. |
8 Guidance for patients
& caregivers
During IVF or embryo transfer cycles, progesterone
supplementation is critical to implantation success. Even if you feel that the
gel is leaking out or see white residue, the bioadhesive properties ensure that
sufficient progesterone has been absorbed. Do not use extra doses if you think
the gel has leaked.
Do not stop using the gel without consulting your fertility
specialist — particularly in early pregnancy. Progesterone supports the uterine
lining and stopping abruptly in early pregnancy can compromise the pregnancy.
Your specialist will advise when it is safe to taper and stop.
The gel is used vaginally — it does not cause the systemic
side effects (e.g. severe nausea) that oral progesterone can, because the
vaginal route delivers progesterone more directly to the uterus with lower
systemic absorption.
9 Pharmacist &
prescriber notes
Crinone 8% and generic equivalents deliver 90 mg of
progesterone per applicator via a bioadhesive polycarbophil base.
Vaginal progesterone achieves high local uterine
concentrations (first-uterine-pass effect) with relatively lower systemic
levels compared to oral or IM routes — this accounts for its excellent uterine
efficacy with fewer systemic side effects.
The 15-applicator pack provides 15 days of once-daily
therapy. For twice-daily protocols (some IVF centres use BID dosing for FET),
15 applicators covers only 7.5 days — confirm exact protocol before dispensing.
Serum progesterone levels are not a reliable guide to vaginal
gel adequacy due to the first-uterine-pass effect — local uterine levels are
high even when serum levels appear moderate.
10 Frequently asked
questions
Can I have intercourse while using the gel?
Your doctor or fertility specialist
will advise based on your clinical situation. During IVF cycles, some
restrictions on intercourse may apply. The gel itself is not a contraceptive.
How long do I need to use this gel?
In IVF cycles, luteal phase support
typically continues until 10–12 weeks of pregnancy, at which point the placenta
produces sufficient progesterone independently. For preterm birth prevention,
use may continue until 36–37 weeks. Your specialist will determine the exact
duration.
Can I use a tampon with the gel?
No — tampons will absorb the gel,
preventing the progesterone from being absorbed. Use a panty liner instead if
needed.
Is it safe to use this gel throughout early pregnancy?
Yes — progesterone gel is safe and
important in early pregnancy, especially after ART. Progesterone is a natural
hormone essential for pregnancy maintenance. Do not stop without your doctor's
instruction.