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

NCT03585712 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 151042-002
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Contraception

Keywords

Birth Control; Progestin Only Pill; Estrogen Free Pill; Norgestrel; Oral Contraception; Female Contraception; Cervical Mucus; Ovarian Activity

Outcome Measures

Primary Outcomes (1)

• Effect of Delayed Intake or Missed Pill on Cervical Mucus Score (CMS)

  Difference in Cervical Mucus Score between baseline (as Day 41 or Day 69) and delayed (Day 42 and Day 70) or missed pill (Day 43 or day 71) The Insler cervical mucus score (0-12) is the sum of 4 subscores: * viscosity from 0 (thick, highly viscous) to 3 (watery,minimally viscous) * ferning from 0 (no crystallization) to 3 (tertiary and quaternary stem ferning) * spinnbarkeit from 0 (\<1 cm) to 3 (\>= 9 cm) * rank for cells from 0 (\>20 cells per High Power Field or \>1000 cells per μL) to 3 (0 cell) A score \<5 is considered as a protective score while a score \>9 is considered as a non protective score

  Day 41 +/- 3 day to Day 43 +/3 days and Day 69 +/- 3 days to Day 71 +/-3 days

Secondary Outcomes (5)

• Duration of Protective Effect of Cervical Mucus After a 6h Delayed or a Missed Pill

  Day 41 +/- 3 day to Day 43 +/3 days and Day 69 +/- 3 days to Day 71 +/-3 days

• Ovarian Status (OS)

  From Day 1 to Day 84 (if no follow-up) or up to Day 90 (if follow-up)

• Cervical Mucus Protection

  From Day 1 to Day 84

• Conception Protection Risk

  Day 1 to Day 84 (up to Day 90 if follow-up)

• Conception Protection Level

  Day 1 to Day 84 (up to Day 90 if follow-up)

Study Arms (2)

Arm A: Delayed then Missed Pill

OTHER

Treatment period 2, Day 42 +/- 3 days: 6 hour delayed intake of Norgestrel 75 mcg Treatment period 3, Day 70 +/- 3 days: missed pill of Norgestrel 75 mcg

Drug: Norgestrel 0.075 mg

Arm B: Missed then Delayed Pill

OTHER

Treatment period 2, Day 42 +/- 3 days: missed pill of Norgestrel 75 mcg Treatment period 3, Day 70 +/- 3 days: 6 hour delayed intake of the pill of Norgestrel 75 mcg

Drug: Norgestrel 0.075 mg

Interventions

Norgestrel 0.075 mg DRUG

Subjects will take norgestrel 75 mcg every day at the same time for three 28-day treatment periods, except for 1 specific day during treatment period 2 and treatment period 3

Also known as: Norgestrel 75 mcg

Arm A: Delayed then Missed Pill; Arm B: Missed then Delayed Pill

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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\< 32 kg/m²
• Regular menstrual cycles between 21 and 35 days when not using hormonal contraception.
• Subjects postpartum or post-abortal must have one normal menstrual cycle (2 menses) prior to enrollment.
• Subjects previously using Intra-Uterine Device (IUD) or taking hormonal contraception (or any other hormonal treatment, except an injectable treatment) need to have at least one menstrual cycle (2 menses) without the treatment before screening.
• Subject previously using an injectable (DMPA), must have had their last injection at least 9 months before screening.
• Women not at risk of pregnancy: not sexually active, or willing to protect all acts of intercourse with condoms, or have a sterile partner or have undergone previous tubal ligation (including validated Essure), or be in a same sex relationship.
• Women able to give informed consent form to participate in the study and in the opinion of the investigator able to follow all study requirements, use the study medication and record the requested information appropriately
• Intact uterus and both ovaries
• At least one progesterone concentration \> 3 ng/mL (\>10 nmol/L) during the luteal phase of the screening period

You may not qualify if:

• 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)

Sponsors & Collaborators

• HRA Pharma: lead
• Premier Research: collaborator

Study Sites (2)

University of California Davis

Sacramento, California, 95616, United States

Location

Oregon Health and Sciences University

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• Edelman A, Hemon A, Creinin M, Borensztein P, Scherrer B, Glasier A. Assessing the Pregnancy Protective Impact of Scheduled Nonadherence to a Novel Progestin-Only Pill: Protocol for a Prospective, Multicenter, Randomized, Crossover Study. JMIR Res Protoc. 2021 Jun 8;10(6):e29208. doi: 10.2196/29208.

  PMID: 33970869 DERIVED

Related Links

• World Health Organization Laboratory Manual for the Examination and Processing of Human Semen. Fifth edition 2010

MeSH Terms

Interventions

Norgestrel

Intervention Hierarchy (Ancestors)

Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Agnes Hemon
• Organization: HRA Pharma

a.hemon@hra-pharma.com

0140337092

Study Officials

• Alison Edelman, MD

  Oregon Health and Sciences University

  PRINCIPAL INVESTIGATOR

• Mitchell Creinin, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2018
• First Posted: July 13, 2018
• Study Start: July 24, 2018
• Primary Completion: April 7, 2020
• Study Completion: April 7, 2020
• Last Updated: June 3, 2021
• Results First Posted: June 3, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)