Infertility
Conditions
Keywords
luteal phase replacement, oocyte donation, infertility, progesterone
Brief summary
This is a single-center, open-label, randomized, active-controlled study to compare DR-2011 to progesterone vaginal gel for luteal phase replacement.
Detailed description
This is a 2-arm, single-center, open-label, randomized, active-controlled study to compare the safety and efficacy of luteal phase replacement with DR-2011 to progesterone vaginal gel over an 18-day treatment period. Patients will also be required to use an estrogen patch during the course of the study. The overall study duration for each patient will be approximately 1½ months. Luteal phase replacement will be monitored by endometrial biopsy on Cycle Day 25 or 26. In addition, serum hormonal levels will be measured at screening and at designated times from Cycle Day 14 to 31.
Interventions
DRUGDR-2011
Administered vaginally from Day 14 to Day 31
DRUGProgesterone 8% Vaginal Gel
Administered vaginally from Cycle Day 14 to Day 31
Sponsors
Duramed Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Not pregnant * Clinically or medically-induced non-functioning or surgically removed ovaries * Clinical investigator believes patient would be eligible for oocyte donation
Exclusion criteria
* Any contraindication to progesterone or estrogen therapy * Undiagnosed vaginal bleeding * History of uterine fibroids or any other conditions that could adversely affect pregnancy success * Hysterectomy * Any contraindication to vaginal drug delivery systems
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adequate endometrial transformation | Cycle Day 25 or 26 |
Secondary
| Measure | Time frame |
|---|---|
| Hormone levels | Duration of study |
Countries
United States
Outcome results
None listed