A clinical study to compare the effect of a single dose of 1.5 mg and 3 mg levonorgestrel on delaying ovulation in women with regular menstrual cycles having different body weights.
- Conditions
- Inhibition of Ovulation in Women Across Body Weight Categories During the Mid-Follicular PhaseMedDRA version: 22.0Level: LLTClassification code 10082354Term: Emergency contraceptive pillSystem Organ Class: 100000004865Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]
- Registration Number
- EUCTR2020-000089-41-GB
- Lead Sponsor
- Foundation Consumer Healthcare (FCH)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 150
1. Provision of signed and dated ICF
2. Stated willingness to comply with all study procedures including attendance at the study center for all study visits as scheduled and completion of diary
3. Healthy adult, ovulatory female
4. Aged at least 18 years but not older than 40 years
5. Non- or ex-smoker (An ex-smoker is defined as someone who completely stopped using nicotine products for at least 180 days prior to the first study drug administration)
6. Occurrence of regular menstrual cycles that typically happen every 24-35 days when not using hormonal contraception (established by medical history over the past 3 months) and that should preferably be of consistent duration within this range. In addition, subject must have a midluteal P4 value of =12 nmol/L to confirm baseline ovulatory status during the screening visit
7. Both ovaries must be present. If both ovaries are not visible on the screening TVU, a confirmatory TVU may be performed on the same day or on a subsequent day within the Screening Visit allowance window.
8. Does not want to become pregnant during the study
9. Use of 1 of the accepted contraceptive regimens from the Screening Visit through to the end of the study. An acceptable method of contraception includes 1 of the following:
· Abstinence from heterosexual intercourse
· Intrauterine device (IUD; without hormones, i.e. copper IUD without drug release)
· Male partner using condom with spermicide or male condom with use of a vaginal spermicide (gel, foam, or suppository)
· Male partner vasectomized at least 6 months prior to the first study drug administration
· Cervical cap with spermicide
or
· Female sterilization procedure
10. At least 1 bleeding episode consistent with menses must have occurred since last use, if the subject has recently used non-injectable hormonal contraception
11. Most recent injection must have occurred at least 6 months before the Pre-Screening Visit, and the subject must have had at least 1 normal menstrual cycle (2 consecutive menses), if there is a history of DepoProvera use
12. At least 2 menstrual bleeds must have occurred since the pregnancy ended, if the subject is postpartum or postabortal
13. Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without clinical significance, as determined by the investigator
14. No clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including vital signs) and/or electrocardiogram (ECG), as determined by the investigator
15. No clinically significant findings on the screening pelvic examination, as determined by the investigator
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Currently lactating/breastfeeding or is within 30 days of discontinuing breastfeeding, unless the subject has already had a menses following discontinuation of breastfeeding
2. Is pregnant according to the pregnancy test at screening or prior to the first study drug administration
3. Currently using any systemic contraceptives (e.g. oral, patch, vaginal ring, injections, implants or hormone-releasing IUD) or any hormone replacement therapy
4. Currently anovulatory (skipped ovulation) as confirmed by a midluteal P4 value of <12 nmol/L at the Screening Visit
5. History of hypersensitivity to LNG or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs (based on medical history, subject's description, and Investigator's interpretation)
6. Presence or history of significant gastrointestinal, liver, or kidney disease, or surgery (including bariatric surgery associated with malabsorption) that may affect drug bioavailability
7. Presence or history of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic, gastrointestinal, renal, urinary, skeletal, dermatologic disease, or breast cancer. Any finding of breast mass during the physical examination will lead to exclusion, and the subject will be referred to her physician for further evaluation
8. Presence of clinically significant ECG abnormalities at the Screening Visit, as determined by the Investigator
9. Presence of abnormal/unresolved vaginal bleeding
10. History of rare hereditary problems of galactose and/or lactose intolerance, lactase deficiency, or glucose-galactose malabsorption
11. Receiving maintenance therapy with any drug if not stable or not controlling the condition or potentially interfering with the menstrual cycle or ovulation, as assessed by the investigator
12. Significant history of drug dependency or alcohol abuse (> 3 units of alcohol per day, acute or chronic intake of excessive alcohol, or chronic daily use of marijuana)
13. Any clinically significant illness in the 28 days prior to the first study drug administration
14. Subjects who never had sexual intercourse
15. History of thrombophlebitis
16. Use of any prescription drugs (including all hormonal contraceptives and hormone replacement therapy) in the 28 days prior to the first study drug administration, that in the opinion of an investigator would interfere with the study treatment or put into question the status of the participant as healthy
17. Concomitant use of drugs and herbal products that induce enzymes that metabolize progestins (including cytochrome P450 3A4 [CYP3A4]) or treatment with human immunodeficiency virus (HIV) protease inhibitors or with non-nucleoside reverse transcriptase inhibitors (Appendix 9)
18. Use of prescription nonsteroidal anti-inflammatory drug (NSAID) in the 28 days prior to the first study drug administration. For acute pain, acetaminophen, per product labeling (e.g. Tylenol) and over-the-counter (OTC) ibuprofen (no more than 200 mg every 6 hours) are allowed per product labeling.
19. Any history of tuberculosis
20. Positive test result for alcohol and/or drugs of abuse at screening or prior to each drug administration
21. Positive screening results to HIV Ag/Ab combo, hepatitis B surface antigen (HBsAG (B) (hepatitis B)), or hepatitis C virus (HCV (C)) tests (if HIV Ag/Ab combo is positive, to be verified by Western Blot or
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method