Ignite Creation Date:
2024-05-06 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05695352
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2023-01-02
Brief Title:
Oral Levonorgestrel Plus Meloxicam IG-002 Delays Ovulation in Normal Menstruating Women by Seven Days
Sponsor:
InnovaGyn Inc
Organization:
InnovaGyn Inc
Study Overview
Official Title:
A Phase II Study to Evaluate the Delay in Ovulation Following Oral Levonorgestrel Plus Meloxicam Compared to Placebo in Normal Menstruating Women
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OVULATION
Brief Summary:
This clinical trial determines if an oral medication taken within 2 days of anticipated ovulation will delay ovulation by 7 days The study compares oral placebo tablets control to oral levonorgestrel a synthetic hormone and meloxicam a non-steroidal anti-inflammatory drug treatment in 21 healthy women between the ages of 18 to 40 The control or treatment are taken 48 hours apart in the first and second menstrual cycle respectively The first dose is taken when the ovarian follicle has a diameter of 17 mm measured by transvaginal ultrasound This follicle diameter is found 2 10 days before ovulation Ovulation is determined by a change in urinary hormone levels analyzed in first morning daily urine The Investigators anticipate that the control cycle will have an interval to ovulation of 3 days from first placebo to ovulation while a delay of 7 days is found between first treatment to ovulation A second question is to determine the side effects between control versus treatment based on symptoms such as nausea or abdominal cramping change in blood pressure or pulse rate and the interval in menstrual bleeding
Each study participant has approximately 9 visits during each of two menstrual cycles The visits between menstrual day 9 first visit to largest follicle are 3 to 6 depending upon follicle growth A blood sample with a transvaginal ultrasound for ovarian follicle diameter is obtained at each visit The appropriate medication is taken when the ovarian follicle largest diameter is 17 mm The second dose is taken 2 days later with interim and final visits at 5 and 10 days following first dose Each participant collects first morning urine from menstrual day 9 to 23 A teaspoonful of morning urine is placed in a storage tube and kept in a refrigerator freezer section until returned at a scheduled visit All urine samples are kept frozen until analyzed for the metabolites of estrogen and progesterone by a central research laboratory A change in the ratio of estrogen to progesterone metabolites is indicative of ovulation because more progesterone is secreted after ovulation from the ovary
The primary research outcome compares the interval in days from first dose of medication to ovulation between control and treatment Secondary outcomes are menstrual cramps vaginal bleeding nausea and headache and changes in blood pressure pulse and interval between menstrual periods in control compared to treatment cycles
Each study participant has approximately 9 visits during each of two menstrual cycles The visits between menstrual day 9 first visit to largest follicle are 3 to 6 depending upon follicle growth A blood sample with a transvaginal ultrasound for ovarian follicle diameter is obtained at each visit The appropriate medication is taken when the ovarian follicle largest diameter is 17 mm The second dose is taken 2 days later with interim and final visits at 5 and 10 days following first dose Each participant collects first morning urine from menstrual day 9 to 23 A teaspoonful of morning urine is placed in a storage tube and kept in a refrigerator freezer section until returned at a scheduled visit All urine samples are kept frozen until analyzed for the metabolites of estrogen and progesterone by a central research laboratory A change in the ratio of estrogen to progesterone metabolites is indicative of ovulation because more progesterone is secreted after ovulation from the ovary
The primary research outcome compares the interval in days from first dose of medication to ovulation between control and treatment Secondary outcomes are menstrual cramps vaginal bleeding nausea and headache and changes in blood pressure pulse and interval between menstrual periods in control compared to treatment cycles
Detailed Description:
The investigators will perform a single site single blind clinical trial to determine the delay in ovulation following administration of placebo or levonorgestrel plus meloxicam in normal menstruating women aged 18 to 40 The Hypothesis is There will be a delay of 7 days between the first dose of combination drug and the occurrence of ovulation compared to 3 days following placebo
The investigators will screen 26 potential participants to enroll and complete 21 Each participant after signing an Informed Consent and meeting all inclusion and exclusion criteria will be enrolled on menstrual day 9 of the subsequent menstrual cycle following a negative urine pregnancy test Each participant will be asked to collect a first morning voided urine sample beginning on menstrual day 9 for 13 days completing on menstrual day 22 The participant will undergo a transvaginal ultrasound on menstrual days 9 12 13 and possibly day 14 to determine ovarian follicle diameters in two planes frontal and sagittal using transvaginal ultrasound When the largest follicle diameter is 1710 mm the participant will be given the assigned intervention Placebo tablets will be given in two doses 48 hours apart in the 1st control cycle and levonorgestrel 15 mg plus meloxicam 15 mg two doses 48 hours apart in the 2nd treatment cycle The ovarian follicle diameter occurs approximately in the middle of the womans window of fertility which is the four days preceding the day of ovulation We anticipate that ovulation will take place within 72 hours after the first placebo dose in 90 of the participants and will be delayed 7 days following the first dose of levonorgestrel 15 mg and meloxicam 15 mg orally in 85 of the participants
The primary outcome is the delay in days from the first dose of medication to evidence of ovulation the formation of a corpus luteum The daily urine samples will be assayed for luteinizing hormone estrone-3-glucuronide and pregnadiol-3-glucuronide by our central laboratory Changes in the urinary metabolites of estrone and progesterone are used to identify the day of the luteal-follicular transition DALT indicating ovulation Urine luteinizing hormone will be analyzed on a subset of the daily urine samples to confirm a LH increase in the placebo cycle Days 12 to 17 and the delay in the LH increase in the levonorgestrel plus meloxicam cycle Days 12 to 19
Secondary outcomes are a the comparison of the symptoms and menstrual interval between treatments b safety parameters consisting of blood pressure and pulse obtained at each visit and the incidence of treatment emergent adverse events captured by the participant using a daily diary card The participant will be instructed to write down any symptoms or problem along with medications taken including study drug and other medications The occurrence percentage and relationship of minor and moderate adverse events will be noted and categorized using Medical Dictionary for Regulatory Activities MedRA adverse event classification for ach intervention placebo and medication and listed in all reports and publications Each participant will be involved for a study period of approximately 30 months or 90 days Each participant will undergo a complete history and physical evaluation at entry and a brief interim history vital signs and physical evaluation at exit with height and weight at entry Mean and standard deviation of all vital signs results and the incidence of adverse events before and after treatment will be compiled and listed in all reports and publications
The investigators will screen 26 potential participants to enroll and complete 21 Each participant after signing an Informed Consent and meeting all inclusion and exclusion criteria will be enrolled on menstrual day 9 of the subsequent menstrual cycle following a negative urine pregnancy test Each participant will be asked to collect a first morning voided urine sample beginning on menstrual day 9 for 13 days completing on menstrual day 22 The participant will undergo a transvaginal ultrasound on menstrual days 9 12 13 and possibly day 14 to determine ovarian follicle diameters in two planes frontal and sagittal using transvaginal ultrasound When the largest follicle diameter is 1710 mm the participant will be given the assigned intervention Placebo tablets will be given in two doses 48 hours apart in the 1st control cycle and levonorgestrel 15 mg plus meloxicam 15 mg two doses 48 hours apart in the 2nd treatment cycle The ovarian follicle diameter occurs approximately in the middle of the womans window of fertility which is the four days preceding the day of ovulation We anticipate that ovulation will take place within 72 hours after the first placebo dose in 90 of the participants and will be delayed 7 days following the first dose of levonorgestrel 15 mg and meloxicam 15 mg orally in 85 of the participants
The primary outcome is the delay in days from the first dose of medication to evidence of ovulation the formation of a corpus luteum The daily urine samples will be assayed for luteinizing hormone estrone-3-glucuronide and pregnadiol-3-glucuronide by our central laboratory Changes in the urinary metabolites of estrone and progesterone are used to identify the day of the luteal-follicular transition DALT indicating ovulation Urine luteinizing hormone will be analyzed on a subset of the daily urine samples to confirm a LH increase in the placebo cycle Days 12 to 17 and the delay in the LH increase in the levonorgestrel plus meloxicam cycle Days 12 to 19
Secondary outcomes are a the comparison of the symptoms and menstrual interval between treatments b safety parameters consisting of blood pressure and pulse obtained at each visit and the incidence of treatment emergent adverse events captured by the participant using a daily diary card The participant will be instructed to write down any symptoms or problem along with medications taken including study drug and other medications The occurrence percentage and relationship of minor and moderate adverse events will be noted and categorized using Medical Dictionary for Regulatory Activities MedRA adverse event classification for ach intervention placebo and medication and listed in all reports and publications Each participant will be involved for a study period of approximately 30 months or 90 days Each participant will undergo a complete history and physical evaluation at entry and a brief interim history vital signs and physical evaluation at exit with height and weight at entry Mean and standard deviation of all vital signs results and the incidence of adverse events before and after treatment will be compiled and listed in all reports and publications
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R43HD104508-01 | NIH | None | httpsreporternihgovquickSearch1R43HD104508-01 |