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ContraceptionNCT06345586

Drospirenone Only Pills and Cervical Mucus Changes: A Pre- and Post-Bariatric Surgery Study

A study testing Drospirenone in people with Contraception, run by Chulalongkorn University at 1 site in Thailand.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this study is to study the effect of Drospirenone on cervical mucus change by modified Insler score, pre-bariatric surgery and post-bariatric surgery Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Contraception
What is being tested?
Drospirenone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteThailand
Study dates
18 Apr 2024to Jul 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Thai women aged 18-45 years who are obese and had an appointment for Bariatric surgery at Chulalongkorn Hospital
  • Need contraception
  • Able to use non-hormonal contraception during the study
  • Giving consent

Who cannot join

  • Pregnancy or history of giving birth within 3 months
  • Breastfeeding within the 6 months
  • History of using DMPA within 12 months
  • History of using other types of hormonal birth control pills within 4 weeks
  • History of bilateral oophorectomy or hysterectomy
  • Suspected ovarian tumor or pathological ovarian cyst
  • Regular cigarette smoking
  • Contraindications to Drospirenone

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Punyawee Utaipatanacheep contact

+668-7515-4003

punyawee@docchula.com

Somsook Santibenchakul contact

+669-2265-7273

dr.somsook@gmail.com

Thailand1 site, 1 recruiting

  • Chulalongkorn University

    Bangkok, 10330

    Punyawee Utaipatanacheep

    Recruiting

Other trials in Thailand

About this study

Official title: Drospirenone Only Pills and Cervical Mucus Changes in Obese Thai Women: A Pre- and Post-Bariatric Surgery Study

The purpose of this study is to study the effect of Drospirenone on cervical mucus change by modified Insler score, pre-bariatric surgery and post-bariatric surgery

Read the detailed description

After being informed about the study and potential risks, all participants giving written informed consent who meet the eligibility requirements will take Drospirenone-only pills (4 mg, once daily). Cervical mucus by modified Insler score will be evaluated on Day 4-7 of Drospirenone taking. Pre-bariatric surgery results will be compared with post-bariatric surgery results.

Conditions
Contraception
Being tested
Drospirenone
Keywords
Drospirenone only pills, Obesity, Bariatric surgery, Roux-en-Y gastric bypass, Cervical mucus
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DrospirenoneDrug

    4 mg tablet once daily

Study groups in NCT06345586
Study groupRoleWhat they receive
DrospirenoneExperimentalParticipants received Drospirenone 4 mg tablet orally once daily for 21-28 days
Receives: Drug: Drospirenone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cervical mucus by modified Insler score

    Modified Insler score (ferning, spinnbarkeit, viscosity, cellularity) according to the World Health Organization (WHO) guidelines 2010 used for prediction and detection of ovulation.

    Score ≥9 favoring fertility, 5-8 intermediate, and ≤4 unfavorable to fertility Comparing pre-bariatric surgery with post-bariatric surgery

    Measured: 1 month before and 1 month after bariatric surgery

Secondary outcomes (2)

  1. Estrogen and progesterone levels versus time

    Serum estrogen and progesterone levels will be measured to evaluate change over time (pattern and value) and assess ovulation

    Measured: 1 month before and 1 month after bariatric surgery

  2. Number of Participants With Treatment-Related Adverse Events

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2024
  2. Study start18 Apr 2024
  3. Primary completionJul 2026 (estimated)
  4. Study completionJul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Model description
Participants received Drospirenone will be assess for cervical mucus change by modified Insler score
Masking
None (open label)
Enrolment
16 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06345586
Sponsor's protocol ID
078066
Status last verified
Mar 2026
First submitted
28 Mar 2024
Last updated
18 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Currently have no recruited participant.

Publications

  • Techagumpuch A, Pantanakul S, Chansaenroj P, Boonyagard N, Wittayapairoch J, Poonthananiwatkul T, et al. Thai Society for metabolic and bariatric surgery consensus guideline on bariatric surgery for the treatment of obese patient in Thailand. JAGST 2021;4:5-18.

  • Simmons K, Edelman A. Contraception in the setting of obesity and bariatric surgery. In: Allen RH, Cwiak CA, editors. Contraception for the medically challenging patient. New York: Springer; 2014. P. 157-80.

  • ACOG practice bulletin no. 105: bariatric surgery and pregnancy. Obstet Gynecol. 2009 Jun;113(6):1405-1413. doi: 10.1097/AOG.0b013e3181ac0544. No abstract available.

    PubMed 19461456

  • Ciangura C, Coupaye M, Deruelle P, Gascoin G, Calabrese D, Cosson E, Ducarme G, Gaborit B, Lelievre B, Mandelbrot L, Petrucciani N, Quilliot D, Ritz P, Robin G, Salle A, Gugenheim J, Nizard J; BARIA-MAT Group. Clinical Practice Guidelines for Childbearing Female Candidates for Bariatric Surgery, Pregnancy, and Post-partum Management After Bariatric Surgery. Obes Surg. 2019 Nov;29(11):3722-3734. doi: 10.1007/s11695-019-04093-y.

    PubMed 31493139

  • Mechanick JI, Apovian C, Brethauer S, Timothy Garvey W, Joffe AM, Kim J, Kushner RF, Lindquist R, Pessah-Pollack R, Seger J, Urman RD, Adams S, Cleek JB, Correa R, Figaro MK, Flanders K, Grams J, Hurley DL, Kothari S, Seger MV, Still CD. Clinical Practice Guidelines for the Perioperative Nutrition, Metabolic, and Nonsurgical Support of Patients Undergoing Bariatric Procedures - 2019 Update: Cosponsored by American Association of Clinical Endocrinologists/American College of Endocrinology, The Obesity Society, American Society for Metabolic and Bariatric Surgery, Obesity Medicine Association, and American Society of Anesthesiologists. Obesity (Silver Spring). 2020 Apr;28(4):O1-O58. doi: 10.1002/oby.22719.

    PubMed 32202076

  • Mengesha BM, Carter JT, Dehlendorf CE, Rodriguez AJ, Steinauer JE. Perioperative pregnancy interval, contraceptive counseling experiences, and contraceptive use in women undergoing bariatric surgery. Am J Obstet Gynecol. 2018 Jul;219(1):81.e1-81.e9. doi: 10.1016/j.ajog.2018.04.008. Epub 2018 Apr 7.

    PubMed 29634911

  • United Nations Department of Economic and Social Affairs, Population Division (2022). World Contraceptive Use 2022 [Internet]. [cited 9 August 2023]. Available from: https://www.un.org/development/desa/pd/data/world-contraceptive-use.

  • Nightingale AL, Lawrenson RA, Simpson EL, Williams TJ, MacRae KD, Farmer RD. The effects of age, body mass index, smoking and general health on the risk of venous thromboembolism in users of combined oral contraceptives. Eur J Contracept Reprod Health Care. 2000 Dec;5(4):265-74. doi: 10.1080/13625180008500402.

    PubMed 11245554

  • Jick H, Jick SS, Gurewich V, Myers MW, Vasilakis C. Risk of idiopathic cardiovascular death and nonfatal venous thromboembolism in women using oral contraceptives with differing progestagen components. Lancet. 1995 Dec 16;346(8990):1589-93. doi: 10.1016/s0140-6736(95)91928-7.

    PubMed 7500750

  • Effect of different progestagens in low oestrogen oral contraceptives on venous thromboembolic disease. World Health Organization Collaborative Study of Cardiovascular Disease and Steroid Hormone Contraception. Lancet. 1995 Dec 16;346(8990):1582-8.

    PubMed 7500749

  • Rosano GMC, Rodriguez-Martinez MA, Spoletini I, Regidor PA. Obesity and contraceptive use: impact on cardiovascular risk. ESC Heart Fail. 2022 Dec;9(6):3761-3767. doi: 10.1002/ehf2.14104. Epub 2022 Sep 14.

    PubMed 36103980

  • Cardiovascular disease and use of oral and injectable progestogen-only contraceptives and combined injectable contraceptives. Results of an international, multicenter, case-control study. World Health Organization Collaborative Study of Cardiovascular Disease and Steroid Hormone Contraception. Contraception. 1998 May;57(5):315-24.

    PubMed 9673838

  • Vasilakis C, Jick H, del Mar Melero-Montes M. Risk of idiopathic venous thromboembolism in users of progestagens alone. Lancet. 1999 Nov 6;354(9190):1610-1. doi: 10.1016/S0140-6736(99)04394-9.

    PubMed 10560680

  • WHO Guidelines Approved by the Guidelines Review Committee. Medical Eligibility Criteria for Contraceptive Use. 5 ed. Geneva: World Health Organization Copyright © World Health Organization 2015.; 2015. p. 156-85.

  • Curtis KM, Tepper NK, Jatlaoui TC, Berry-Bibee E, Horton LG, Zapata LB, Simmons KB, Pagano HP, Jamieson DJ, Whiteman MK. U.S. Medical Eligibility Criteria for Contraceptive Use, 2016. MMWR Recomm Rep. 2016 Jul 29;65(3):1-103. doi: 10.15585/mmwr.rr6503a1.

    PubMed 27467196

Questions about this trial

What is this clinical trial studying?

A study testing Drospirenone in people with Contraception, run by Chulalongkorn University at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Punyawee Utaipatanacheep (+668-7515-4003, punyawee@docchula.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cervical mucus by modified Insler score (time frame: 1 month before and 1 month after bariatric surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06345586, which also lists 33 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.

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