Vaginal Progesterone Supplementation in Women With PCOS Undergoing Ovulation Induction With Letrozole

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

July 6, 2012

Primary Completion Date

November 2, 2016

Study Completion Date

December 30, 2017

Conditions
Polycystic Ovary Syndrome
Interventions
DRUG

Progesterone Vaginal Gel 8%

progesterone supplementation for luteal phase support administered with vaginal applicators and used instead of progesterone intramuscular injections or progesterone vaginal suppositories.

DRUG

Letrozole Oral Tablet

letrozole oral tablet 2.5 mg or 5 mg administered cycle day 3-7 for ovulation induction

DIAGNOSTIC_TEST

pelvic ultrasound

pelvic ultrasound performed at cycle day 11 or 12 and repeated as necessary until leading follicle size is \>17 mm in diameter

DRUG

Ovidrel 250 MCG Per 0.5 ML Prefilled Syringe

ovidrel 250 mcg given when leading follicle size is \> 17 mm in diameter

OTHER

Intrauterine insemination or timed intercourse

Intrauterine insemination or timed intercourse (depending on semen parameters) performed 36-40 hours after Ovidrel

Trial Locations (1)

23507

Laurel A. Stadtmauer, MD, PhD, Norfolk

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Watson Pharmaceuticals

INDUSTRY

lead

Eastern Virginia Medical School

OTHER

NCT03440359 - Vaginal Progesterone Supplementation in Women With PCOS Undergoing Ovulation Induction With Letrozole | Biotech Hunter | Biotech Hunter