Phase 2 N=52 Randomized Treatment

Effect of Norgestrel 75 mcg on Cervical Mucus and Ovarian Activity During Perfect Use, After One Delayed Intake and After a Missed Pill

Contraception

Bottom Line

View on ClinicalTrials.gov: NCT03585712 ↗

Enrolled (actual)

Serious AEs

1.0%

Results posted

Jun 2021

Primary outcome: Primary: Effect of Delayed Intake or Missed Pill on Cervical Mucus Score (CMS) — 1.0; 0.7; 0.1; 0.3 changes in scores on a scale — p=0.26

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Norgestrel 0.075 mg (Drug)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: HRA Pharma
Primary completion: Apr 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Effect of Delayed Intake or Missed Pill on Cervical Mucus Score (CMS)	1.0; 0.7; 0.1; 0.3	0.26
SECONDARY Duration of Protective Effect of Cervical Mucus After a 6h Delayed or a Missed Pill	30; 30; 38; 37; 5; 4	>0.999
SECONDARY Ovarian Status (OS)	7; 10; 7; 25; 22; 25	<0.001 sig
SECONDARY Cervical Mucus Protection	32; 27; 28; 17; 20; 15	0.127
SECONDARY Conception Protection Risk	46; 42; 41; 3; 4; 5	—
SECONDARY Conception Protection Level	46; 42; 41; 3; 4; 3	—

Summary

Norgestrel 75 mcg is a progestin-only pill (POP), which is a kind of oral birth control pill. To be effective in preventing pregnancy, this kind of birth control pill is supposed to be taken every day at the same time, without delaying the intake for more than 3 hours. This study aims to find out if taking the pill 6 hours late or not taking it for one day will affect the way it works.

Eligibility Criteria

Inclusion Criteria

Women in good overall health with no chronic medical conditions that result in periodic exacerbations that require significant medical care
Women between 18 and 35 years inclusive at the screening visit
BMI 3 ng/mL (>10 nmol/L) during the luteal phase of the screening period

Exclusion Criteria

Pregnant as confirmed by positive high-sensitivity urine pregnancy test at enrollment visit
Trying to conceive or desire to conceive in the next 3 months
Currently breastfeeding, or within the last 2 months
Known Polycystic Ovarian Syndrome (PCOS)
Cancer (or past history of any carcinoma or sarcoma)
Known abnormal thyroid status, if in clinical judgment of the investigator it cannot be controlled during the study
Known hypersensitivity to the ingredients of the test active substances or its excipients
Current acute liver disease and/or benign liver tumors
Have vaginal or cervical infection including clinical evidence of bacterial vaginosis
Evidence of abnormal cervical lesion
History of excisional or ablative treatment procedure on cervix (ie. Loop Electrosurgical Excision Procedure (LEEP), Cryotherapy, Cold Knife Cone)
Undiagnosed abnormal uterine bleeding
Prior malabsorptive-type bariatric surgery
Known or suspected alcoholism or illicit drug abuse
Use of any hormonal contraception or IUD other than the study medication during the study (including ulipristal acetate for emergency contraception in the past 5 days)
Use of any medications that can interfere with the metabolism of progestin-based contraceptives (e.g CYP3A4 enzymes inducers or inhibitors, etc)
Unstable diabetes mellitus
Current participation in any other trial of an investigational medicine or participation in the past two months (or within 5 elimination half-lives for chemical entities or 2 elimination half-lives for antibodies, whichever is the longer) before screening
Abnormalities in laboratory results or TVUS performed at screening visit recognized as clinically significant by the investigator
Conditions not suitable for frequent TVUS examinations, (e.g. virgo intacta)
In custody or submitted to an institution due to a judicial order
Relative or household member of the investigator's or sponsor's staff

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03585712). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.