Infertility, Pregnancy
Conditions
Keywords
Assisted reproductive technology, Infertility, Progesterone, Vaginal gel, Luteal-phase support
Brief summary
The purpose of this study is to determine if sexual intercourse lowers serum progesterone in women using vaginal progesterone gel (Crinone®), and increases serum progesterone in their male sexual partners. We hypothesize, based on previous estrogen studies done by our group, that intercourse will interfere with absorption of vaginal progesterone.
Detailed description
The effects of intercourse on the absorption of vaginal progesterone for the female user and her sexual partner have not been studied. However, a previous study performed by our group found that intercourse lowered the absorption of vaginal estrogen cream in women, and men absorbed a small but statistically significant amount of estradiol during intercourse. Vaginal progesterone gel may be used by women for several clinical indications, and if intercourse alters the absorption and distribution of vaginal progesterone, clinical outcomes may be compromised. If intercourse lowers absorption, the efficacy of the treatment could be reduced. If intercourse enhances absorption, side effects may be increased. Also, if the male sexual partner absorbs vaginal progesterone, undesirable side effects may occur.
Interventions
DRUGCrinone vaginal progesterone gel
Crinone vaginal progesterone gel is inserted in the female vaginal using the pre-filled applicator.
Placebo vaginal gel is inserted in the female vagina using the pre-filled applicator.
Sponsors
Carolinas Medical Center
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Initial assignment randomized, then crossed over to the other treatment
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Sexually active 18-40 year old heterosexual couple * Subject willing to take Mircette birth control pills for at least one cycle (one pack) * Willing to have intercourse at the defined times (at least weekly within a 3 week interval, and draw blood within 10 hours of intercourse) * IRB signed informed consent
Exclusion criteria
* Undiagnosed vaginal bleeding * Contraindication to oral contraceptives * Liver dysfunction or disease * Known sensitivity to Crinone * Known or suspected malignancy of the breast or genital organs * History of or active thrombophlebitis or thromboembolic disorders * Use of condoms during intercourse * Male erectile or ejaculatory dysfunction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Female Change in Progesterone | 3 weeks | The primary outcome variables will be: the change in serum progesterone levels increase after coitus in the female partner using vaginal progesterone gel compared to placebo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Male Change in Progesterone | 3 weeks | The secondary outcome variable will be the change in serum progesterone levels after coitus in the male partner comparing vaginal progesterone gel and placebo. |
Countries
United States
Participant flow
Pre-assignment details
Women were enrolled into the study to receive the intervention; male partners also had blood samples taken
Participants by arm
| Arm | Count |
|---|---|
| Crinone Vaginal Progesterone Gel Then Placebo Crinone is a bioadhesive vaginal gel containing micronized progesterone in an emulsion system containing a water swellable but insoluble polymer, polycarbophil. Crinone 8% is formulated to provide a long-acting vaginal retention, and is prescribed daily. Each applicator delivers 1.125 grams of Crinone gel containing 90 mg of progesterone. The reported time to maximum progesterone concentration is 6.8 +/- 3.3 hours with use of a single dose of Crinone 8%. Absorption half-life is approximately 25-50 hours and an elimination half-life of 5-20 minutes.
On the evening of day 3, the female will insert the applicator into the vagina, administer the Crinone gel, and have intercourse within 1 hour of insertion of the cream. Then she will cross over to placebo. | 10 |
| Placebo Vaginal Gel Then Crinone The couple will be given a prefilled applicator containing placebo vaginal gel, data collection sheets and laboratory requisitions. On the evening of day 3, the female will insert the applicator into the vagina, administer the gel, and have intercourse within 1 hour of insertion of the cream. Then she will cross over to Crinone. | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Total | Crinone Vaginal Progesterone Gel Then Placebo | Placebo Vaginal Gel Then Crinone |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 10 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants | 9 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Region of Enrollment United States | 20 participants | 10 participants | 10 participants |
| Sex: Female, Male Female | 20 Participants | 10 Participants | 10 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Female Change in Progesterone
The primary outcome variables will be: the change in serum progesterone levels increase after coitus in the female partner using vaginal progesterone gel compared to placebo
Time frame: 3 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Placebo Vaginal Gel | Female Change in Progesterone | 0.8 ng/ml |
| Crinone Vaginal Progesterone Gel | Female Change in Progesterone | 7.0 ng/ml |
Secondary
Male Change in Progesterone
The secondary outcome variable will be the change in serum progesterone levels after coitus in the male partner comparing vaginal progesterone gel and placebo.
Time frame: 3 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Placebo Vaginal Gel | Male Change in Progesterone | 0.54 ng/ml |
| Crinone Vaginal Progesterone Gel | Male Change in Progesterone | 0.85 ng/ml |